Decoding Baby Formula: How US and European Standards Compare

From nutrients to labeling laws, understanding what sets U.S. and European infant formulas apart can help parents make more informed choices.
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From the moment that Jess Davidoff’s infant son transitioned from breast milk to baby formula, feeding became a source of distress—for both mom and baby. Every bottle of any U.S.-made brand seemed to trigger a bout of vomiting, his tiny body rejecting each feeding. Davidoff took to research, and against her doctor’s guidance, made the switch to a European-made formula. The vomiting stopped with the swap, granting a sliver of respite for both baby and mom.

“My pediatrician told me that I was ‘endangering’ him by using a European formula that wasn’t [Food and Drug Administration-approved],” Davidoff told The Epoch Times.

However, as she discovered, her pediatrician’s warning didn’t quite align with reality. The debate over what makes a “good” infant formula is intensifying as American parents increasingly turn to European brands. Interest in overseas products isn’t just about preference—it also highlights significant disparities in regulatory standards, essential fats, controversial carbohydrates, and transparent labeling. Understanding these differences empowers parents to make informed choices for their children and supports the health and development of American infants.

‘Good’ Formula

Choosing the best formula requires understanding labels and ingredients, regardless of its country of origin. Several critical factors come into play:

Essential Nutrients

Infant formula serves as the primary source of nutrition for many babies during their first year, making its composition essential for healthy development. Key nutrients found in breast milk to look for in formula include:
Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA): These long-chain polyunsaturated fatty acids are essential for brain and eye development. European regulations have historically mandated minimum levels of DHA in infant formula, whereas the amounts in U.S. formulas may vary and are, on average, much lower than what Europe requires.
Prebiotics and Probiotics: Gut health is vital for babies’ digestion, immunity, and even brain development. Regulations regarding the inclusion of prebiotics and probiotics, and the specific strains and amounts, can vary between the United States and Europe. European standards often impose stricter guidelines.
Vitamins and Minerals: Both the Food and Drug Administration (FDA) and European authorities set minimum, and sometimes maximum, levels for micronutrients in infant formula to ensure that babies receive adequate nutrition. However, the specific requirements for certain vitamins and minerals can differ. A 2023 study published in Nutrients found that the average iron level in U.S. formulas is higher than what Europe allows. Almost 96 percent of the formulas tested in the United States exceeded the European iron limit.

Quality

The quality of ingredients and how they are processed can affect the overall nutritional value and potential health effects of infant formula.
Organic formulas, made with milk from cows raised without hormones or routine antibiotics and fed organic feed, are more prevalent and strictly regulated in Europe. European organic formulas are also more likely to be made from grass-fed cows and contain probiotics.

The organic market in the United States is growing, but conventional formulas produced from cows raised according to standard agricultural practices still dominate.

Processing methods can affect the bioavailability of nutrients, such as milk proteins and calcium. Some newer processing methods aim to preserve more heat-sensitive nutrients. While both U.S. and European manufacturers follow safety standards, the specific techniques they use might vary.
Additives, such as emulsifiers, stabilizers, and preservatives, are common in formula, but the types and amounts allowed are more restricted in Europe. Some ingredients found in U.S. formulas might be restricted or banned in Europe because of potential health concerns, including exposure to antibiotics and pesticides.

Macronutrient Content

When it comes to macronutrients, lactose is the primary carbohydrate used in both regions to mimic breast milk. It is generally well-digested by infants and supports the growth of beneficial gut bacteria. However, European standard formulas almost exclusively use lactose, while U.S. formulas use corn syrup solids, which may affect blood sugar, weight gain, and gut health. Because of these concerns, European regulatory bodies tend to be more cautious than the United States about allowing corn syrup solids in standard infant formulas.

For Davidoff’s son, who regurgitated his formula, it turned out that he had a severe corn allergy and was reacting to the corn syrup solids in the U.S. formula.

According to Dr. Michelle Perro, an integrative pediatrician with more than four decades of experience, the corn syrup solids are highly processed, but there may still be residual corn protein in the formula. She told The Epoch Times that producing corn syrup involves extensive processing, which, in her view, may contribute to health issues in some children.

“We are seeing an explosion of food sensitivities, intolerances, and allergies—it is off the charts,” Perro said.

The corn allergy of Davidoff’s son manifested with multiple concerning symptoms, including thinning hair and nails, vomiting, eczema, and hernias—one of which required surgery. Thirty-two doctors dismissed Davidoff’s concerns about a food-related cause, but her mother’s intuition prevailed. She meticulously tracked her son’s food until the culprit revealed itself: U.S.-based formula containing corn.

“The sugar used has to change,“ Perro said. ”We cannot use the synthetic corn syrup derived from GMO corn.”

Both European and U.S. formulas typically use a blend of vegetable oils to mimic the fatty acid profile of breast milk. Common oils include palm oil, soy oil, coconut oil, and sunflower oil. European formulas often highlight the inclusion of medium-chain triglycerides, which are easily digestible and provide a quick source of energy. There may also be a greater emphasis on the quality and processing of these oils compared with U.S. standards.

Proteins in formula—usually cow’s milk—aim to match breast milk’s whey-to-casein ratio. European formulas often match it more closely than U.S. varieties. Both markets offer formulas with partially or extensively broken down hydrolyzed proteins. Additionally, both the United States and Europe offer formulas made with goat’s milk or soy protein for infants with specific dietary needs. Regulations regarding these alternative protein sources and the extent of processing may differ by region.

Ultimately, transparent labeling is essential for parents making informed choices about infant formula ingredients and nutrient content. European standards often provide more detailed information about ingredient sources and the specific types and amounts of certain components, such as prebiotics and probiotics.

Heavy Metals Are a Concern

Heavy metals can be present in baby formula in the United States and Europe. The European Union (EU) generally has stricter limits on heavy metals and contaminants in baby formula than the United States, and continuously updates its regulations to reduce allowable levels. The stricter regulations on heavy metals are a major reason that some parents prefer European formulas.
The FDA does not currently require manufacturers to routinely test infant formula for heavy metals. Instead, it has a “Closer to Zero“ initiative that aims to gradually reduce the amount of harmful metals babies and children are exposed to in food. The initiative focuses on conducting research, setting guidelines for the food industry, and monitoring progress over time.
Perro referenced the FDA’s Total Diet Study, a program that has been running since the 1960s that was initially focused on measuring radioactivity in food. The study, conducted periodically, monitors the safety and nutritional quality of the U.S. food supply. In its most recent publication, released in 2022, the Total Diet Study analyzed approximately 910 foods to assess contaminant levels. Of the 910 foods, four were infant formulas—and two of those contained toxic metals, including uranium. Despite these findings, Perro said, no public recalls or follow-up investigations were announced, raising concerns about regulatory oversight.

“To think that the FDA is protecting us is a stretch,” she noted, voicing frustration over what she sees as inadequate action regarding contamination in infant formula.

Perro suggested that potential sources of toxic metals could include cow feed, processing methods, and environmental factors such as geoengineering—large-scale climate interventions such as solar radiation management. While further research is needed to pinpoint the source in the U.S. formula manufacturing system, the presence of these metals is alarming because of the potential health effects.

Heavy metals found in infant formula and their effects include:
Lead: Per the FDA, there is no known safe level of exposure to lead. It poses the greatest risk during brain development and can cause neurological impairments, including learning and behavioral difficulties and lower IQ.
Mercury: Mercury exposure during active brain development may cause reduced intelligence, memory and cognitive problems, and motor skill difficulties. Emerging evidence also suggests that attention may be affected, according to the FDA.
Arsenic: The FDA links arsenic exposure with adverse neurological effects such as learning disabilities, behavioral difficulties, and reduced IQ. Fetuses, infants, and children are especially vulnerable because of their smaller bodies and rapid development.
Cadmium: Because the body eliminates cadmium slowly, long-term exposure can weaken bones and may contribute to kidney and reproductive problems, heart disease, and diabetes, according to the FDA.
A 2024 meta-analysis published in Science of the Total Environment concluded that cadmium exposure is strongly associated with an increased risk of developing chronic kidney disease. Researchers reviewed 31 studies and found that even small amounts of cadmium exposure pose a long-term concern because of its persistence in the body.

Perro said one of the most troubling effects of heavy metal exposure in infants is its effect on gut health and the subsequent lifelong repercussions.

She explained that toxic metals can disrupt the microbiome, potentially preventing babies from developing a healthy innate immune response. According to Perro, this kind of gut disruption could set the stage for conditions such as eczema, gut-induced asthma, autoimmune disorders, and food allergies, possibly leading to additional health challenges later in life.

She also emphasized the neurological effects of toxic metals, which she believes may play a role in the progression of neurodevelopmental conditions such as autism spectrum disorder, attention deficit hyperactivity disorder, sensory processing disorders, sleep disturbances, and other behavioral challenges. Additionally, Perro expressed concern about possible metabolic disruptions and the long-term risk of kidney disease, particularly from cadmium exposure.
“Whatever happens to baby is setting up that baby for their immunologic well-being for the rest of their lives,” she said.

The Realities of Importing Formula

The fundamental differences between U.S. and European formulas motivate many American parents to seek alternatives.

A significant concern among medical professionals in the United States is the availability of “gray market” or imported formulas that are not cleared by the FDA. Unless explicitly imported under FDA oversight, these products are sold in the United States by third-party vendors and don’t fully comply with FDA labeling requirements.

Gray market formulas have not undergone the FDA’s safety and nutrient content review. The lack of regulation raises questions about whether these formulas meet the specific nutritional needs of American infants and adhere to U.S. safety standards. Parents purchasing these formulas often do so without the assurance of regulatory oversight.

However, research shows that most of these products do, in fact, meet FDA nutrient requirements. A 2019 study published in the Journal of Pediatric Gastroenterology and Nutrition investigated imported European infant formulas sold online in the United States and assessed them according to FDA standards. The researchers identified 16 popular formulas from online vendors and blogs. They found that while none of the 16 formulas fully met FDA labeling requirements, 15 met FDA nutrient requirements—excluding linoleic acid, which was often missing from labels.
The EU also often operates under the Precautionary Principle—if there’s uncertainty about an ingredient’s safety, it’s restricted or banned until proven safe. Compared with formulas in the United States, which generally has a more “proof-based” system in which ingredients are assumed safe until proven otherwise, European formulas may be the better choice.

What Can Parents Do?

Navigating the world of infant formula can feel overwhelming, but parents can empower themselves by being informed consumers. When choosing a formula, it’s best to prioritize options that follow the most stringent standards.

“I tell parents to stick to organic whenever you can,“ Perro said. ”There might still be some toxic metals, but they'll get less pesticides.”

Seeking recognized certifications such as the U.S. Department of Agriculture organic seal for U.S. products or the EU organic logo for European formulas is key.

Beyond organic certification, it’s also crucial to read labels carefully. Pay close attention to the carbohydrate source, noting whether lactose is the primary ingredient and being mindful of the presence and amount of corn syrup solids. Scrutinize the list of additives. Perro also recommends being cautious of formulas containing any high fructose corn syrup.

“We are trying to induce change here, not fear and panic, so we do the best we can,” Perro said, highlighting an approach rooted in parental empowerment.

She advises parents to use the highest-quality formula they can find, while ensuring that their baby’s digestion is good and that they are eliminating regularly. She also strongly recommends using the best water filter you can afford to mix formula instead of using tap water, which may contain fluoride, lead, pesticides, or other potential contaminants, depending on your location.

In addition to education and empowerment, Perro said she is hopeful about the future of the formula market in the United States.

“People see the potential here for growth,“ she said. ”The companies are coming, and I think they’re going to be producing a better formula.”

Where there is a need, there is always an opportunity.

New U.S.-based formula companies are likely following suit, developing products that are free of unwanted additives. By demanding greater transparency and higher quality, parents can shape the future of infant formula in the United States.

Jennifer Sweenie
Jennifer Sweenie
Author
Jennifer Sweenie is a New York-based health reporter. She is a nutritional therapy practitioner and trained health-supportive chef focused on functional nutrition and the power of natural, whole foods. Jennifer serves on the board of directors for Slow Food NYC and is a former board member of the Farm-to-Consumer Foundation.