Why US Parents Are Choosing European Baby Formula

[Editor’s note June 24, 2022: With the ongoing baby formula shortage in the US, the FDA is now allowing domestic sales of a few formulas from abroad that meet certain criteria. For more information on these formulas, see “Foreign formulas temporarily available in the US.”

Some popular European formulas, including from the brands HiPP and Holle, remain non-FDA-regulated and may be detained by customs if imported.

This article was published March 12, 2021 and is not being updated.]

There are more than 50 different baby formulas available in the US. Parents can choose among formulas made from conventional or organic milk or soy; they can also opt to try formulas labeled for fussy, gassy, or colicky babies. And baby formula is one of the most tightly regulated food products in the US, with the Food and Drug Administration (FDA) dictating the nutrients and vitamins, and setting strict rules about how formula is produced, packaged, and labeled.

Despite this, a growing number of parents are buying European formulas, even though it’s technically illegal to import them to the US. There are large Facebook groups devoted to European formulas, where parents share spreadsheets and detailed notes on ingredients and how these formulas compare to their US counterparts. Some caregivers report choosing them because European brands offer certain formula options (like those made from goat’s milk or milk from pasture-raised cows), which are rare or nonexistent in an FDA-regulated form in the US. Others seek out European brands because of the perception that the formulas are of higher quality and that European formula regulations are stricter.

Parents in the US who buy European formulas pay a premium. For example, on various websites that sell imported EU formulas, Holle Organic Formula from Germany costs about $26 for a 400-gram box, or about $1.70 to make a 6-ounce bottle. The top picks in our guide to the best baby formula cost about 45¢ to make a 6-ounce bottle.

To find out just how different European formulas are from US versions, and to see whether they meet FDA guidelines, Anthony Porto, a pediatric gastroenterologist and pediatrics professor at Yale University, led a study to analyze European formulas, including popular brands like HiPP, Holle, Kendamil, Topfer, Loulouka, and Lebenswert.

The study’s authors concluded there are safety concerns that arise from importing these formulas. For one, the instructions for some European formulas are written in Dutch or German, making it tough for English-speaking parents to prepare the formulas properly. European formulas are mixed differently than US formulas—one scoop for 1 ounce of water, instead of the US standard of one scoop per 2 ounces of water; this could cause a parent to inadvertently dilute their baby’s formula. Also, Porto noted, it’s impossible to know whether European formulas were transported under safe temperature conditions (the FDA does not inspect imported formula for safety, and European formula shipments may be detained if detected because they don’t meet FDA requirements). It would also be difficult to find out whether the formulas were subject to recall in the EU. The Dietary Guidelines for Americans (PDF) issued by the Department of Agriculture take a firm stance: “Homemade infant formulas and those that are improperly and illegally imported into the United States without mandated FDA review and supervision should not be used.”

Porto’s team did find that European formulas generally meet most of the FDA nutritional guidelines, even if the foreign formulas are not FDA-approved. The opposite is not always the case. “The European commission does have additional regulations on formula that the FDA does not,” said Bridget Young, PhD, a professor of pediatrics at the University of Rochester School of Medicine and Dentistry and founder of an informational website on baby formula. For example, the EU bans certain added sugars, like corn syrup, from traditional milk-based formulas, and it requires that at least 30% of the carbohydrates come from lactose, the energy-giving carbohydrate in human milk. Porto and Young agreed that a formula with lactose as the main sugar is preferable for most babies. And it’s not difficult to find formulas in the US that meet the EU’s carbohydrate requirements (including the formulas we recommend in our guide).

The EU and US require most of the same vitamins and minerals in baby formula. The most notable differences involve iron and the omega-3 fatty acid DHA. Many formulas in the US contain more iron than their European counterparts do; the American Academy of Pediatrics recommends a higher iron level to prevent iron deficiency, which can have lasting neurodevelopmental effects. By contrast, the EU recently began requiring DHA in much higher levels than are found in most formulas available in the US (the FDA does not require DHA at all, but most US formulas have it). Although more DHA is safe (and Young pointed out that breast milk contains a wide range of DHA levels), research doesn’t conclusively support the benefits of the higher amounts found in European formulas.

Currently, the only US formula that would meet the EU’s requirements for DHA is the new infant formula Bobbie. As a self-described “European-style” formula, Bobbie is marketed as an FDA-regulated alternative to European formulas. Bobbie’s iron levels are within the EU’s limits. And, like European formulas, Bobbie lacks many of the “extra” ingredients found in other US organic formulas: lutein, beta-carotene, taurine, nucleotides, and L-carnitine (it does have naturally occurring L-carnitine, as do all milk-based formulas). Though these components are found in breast milk, not all have research showing whether they are beneficial when added to formula.

Some parents choose EU formulas because there are more milk-based options, including some made with whole milk. In the US, all milk-based formulas—including Bobbie—take away the milk fat and then add in plant-based fats, Young said. However, there may be benefits to milk fat. One studied component of milk fat is milk fat globule membrane (MFGM). Some of Enfamil’s premium formulas add MFGM because a few (industry-affiliated) studies have shown it provides a modest infection defense and cognitive benefit for infants, for example. Young pointed out that if a formula is based on whole milk, “they’re going to be getting some of that natural milk fat globule membrane.”

The EU also has goat’s-milk-based formulas (the FDA doesn’t ban infant formula made from goat’s milk, but no company currently makes one that meets FDA regulations). One reason caregivers are drawn to these formulas is a belief that they are more “hypoallergenic,” referring to sensitivities or allergies to cow’s milk. However, Porto said if an infant had an allergy to cow’s milk (which he said is not common), they would likely react to goat’s milk as well.

European formulas also have “gentle” options that aren’t currently available in the US. If a caregiver wants (or a doctor recommends) a “gentle” formula with partially broken-down, or hydrolyzed, proteins, in the US all of these formulas also contain corn sugar (either maltodextrin or corn syrup). In Europe there are partially hydrolyzed formulas with lactose as the sole carbohydrate, which experts prefer for most babies. In the US, Parent’s Choice Tender, Gerber Good Start GentlePro, and Enfamil Reguline are the only partially hydrolyzed formulas that have no intact proteins and contain at least 50% lactose, with the remainder of their carbohydrates coming from corn-based sugars.

For caregivers who want formulas made from organic milk from grass-fed cows, European formulas previously were the only option. Even though organic formulas (such as Earth’s Best Organic Infant Formula, a pick in our guide) have long been available, and Similac’s Pure Bliss is made from (non-organic) milk from grass-fed cows, Bobbie is the only infant formula on the US market that sources its milk from cows who meet both organic and pasture-raised criteria. But Bobbie costs $24 for a 400-gram can (about $1.60 to make a 6-ounce bottle), which is nearly four times more than most of the other formulas we recommend.

Although there are differences between European and US baby formulas, most of them are relatively minor. And medical experts we talked with don’t think the theoretical advantages to European formulas are worth the possible risks and expense. “There is a wide variety of regulated infant formulas available in the US,” Young pointed out. “This variety assures parents that they can find a formula that works for their unique baby and fits in their budget.”