In the more than 150 years they’ve been available, baby formulas have improved at delivering the complex mix of nutrients infants need to thrive.

These days, every baby formula you find in the U.S. is tightly regulated by the Food and Drug Administration (FDA) for what they contain, how they’re manufactured and even how they’re stored. When seeking the right formula for their baby, some parents look to European brands, which are not always FDA-regulated. There are a few essential things to consider when evaluating your options.

To help you pick the right formula for your baby, we consulted our experts, Liliane Diab, MD, Medical Director of the Nutrition Clinic, and Whitney Gillies, MHA, RD, Director Clinical Nutrition.

Why FDA regulation matters

In the U.S., all infant formulas are required to meet strict, evidence-based nutrition requirements designed to get them as close as possible to the nutrition profile of breastmilk. The FDA also requires infant formula manufacturers to follow Good Manufacturing Practices (GMP), which ensures the formulas are safe and free from infectious agents. The FDA conducts frequent inspections of products and facilities, and if something goes wrong, they can recall the products.

Some European formulas, particularly those purchased online through third-party sellers, are not regulated by the FDA. These unregulated formulas haven't undergone the safety testing, labeling review or facility inspections required by U.S. law. As such, they are technically illegal to sell in the U.S. and may carry risks related to contamination, mislabeling or improper preparation. In addition, formulas from third-party sources can be shipped improperly, potentially exposing the formula to excessive heat, which can degrade some of the nutrients. Finally, if a European formula company has a problem or contamination and issues a recall, there's a chance people in the U.S. would not be notified.

Some international formulas are now regulated by the FDA

In response to the 2022 U.S. infant formula shortage, the FDA allowed certain international manufacturers to temporarily import products that met U.S. safety and nutritional standards. Many of these brands have continued selling in the U.S. under ongoing FDA authorization.

International formulas currently regulated by the FDA or authorized for sale in the U.S. include:

• Kendamil (UK) is now widely available in U.S. stores and online, offering organic and classic whole milk formulas.
• Bubs (Australia) offers cow’s milk and goat’s milk formulas that are now sold in the U.S. under FDA authorization.
• Aptamil (Danone) offers select formulas that have been FDA-regulated for the U.S. market.
• Nestle NAN offers certain FDA-authorized products that meet U.S. nutritional and manufacturing standards.

These products meet FDA safety requirements and can be trusted for use in the U.S.

Understanding key differences between U.S. and European formulas

While both U.S. and European formulas are designed to support healthy infant growth, there are differences worth noting:

• Iron: U.S. formulas generally contain more iron to meet American Academy of Pediatrics (AAP) recommendations. European formulas often contain less.
• DHA and ARA: DHA is required in Europe. It's optional in the U.S. but commonly added.
• Carbohydrates: Most standard infant formulas in Europe and the U.S. use 100% lactose as the primary carbohydrate, mirroring the natural sugar found in breastmilk. Common U.S. formulas with 100% lactose include Similac Advance, Enfamil NeuroPro Infant and Bobbie Infant Formula. Some formulas designed for sensitive stomachs or lactose intolerance may reduce or remove lactose and replace it with other carbohydrates, such as corn syrup solids or maltodextrin. These ingredients are approved for use in infant formula and provide an easy-to-digest source of energy. While they don’t offer the same gut health benefits as lactose, they can be helpful for babies who have trouble digesting lactose. In Europe, sensitive formulas more commonly use alternatives like maltodextrin or starch. The best choice depends on your baby’s individual needs. It’s always a good idea to talk with your healthcare provider when choosing a formula.
• Prebiotics and probiotics: Many, but not all, U.S. formulas include prebiotics and probiotics. Meanwhile, all European formulas include these.
• Preparation differences: Parents should also know that preparing European baby formulas can be tricky since the instructions are often not in English. The scoop sizes are different, too, and if you lose the scoop, you can’t replace it without ordering more formula. Using the incorrect ratio can lead to dehydration or malnourishment for your baby.
• Oversight: U.S. formulas are regulated by the FDA. European formulas follow guidelines set by the European Food Safety Authority (EFSA) and are not regulated by U.S. authorities unless the manufacturer registers with the FDA and complies with all applicable U.S. nutritional and safety requirements.

U.S.-made formulas with a European-style approach

Some formulas made in the U.S. are inspired by European nutritional standards and ingredient preferences while still meeting all FDA requirements. They commonly use lactose as the primary carbohydrate, include DHA, and focus on clean, organic ingredients. While most have iron levels typical for U.S. formulas, some provide lower iron content, which is more in line with European products.

• Bobbie is an organic formula with lower iron than most U.S. formulas, modeled after European nutrition profiles and made with 100% lactose.
• ByHeart features a whole-milk base and provides iron levels similar to other U.S. formulas, and it was launched after completing a full clinical trial.
• Pure Bliss by Similac is made with grass-fed milk from Ireland and includes DHA, but it is not USDA Organic-certified.
• Happy Baby Organic is certified organic in both Europe and the U.S. and is manufactured in Europe.

These formulas are not affiliated with European brands but were developed to appeal to families seeking formulas with organic ingredients, minimal processing and thoughtful sourcing. Many formulas produced by American companies using U.S. standards also contain DHA and use lactose as the primary carbohydrate unless specifically designed for sensitive digestion.

What to remember when choosing the right formula for your baby

At Children’s Colorado, we recommend breastfeeding but understand that is not always an option. When formula is needed, we’re here to help you pick the best one for your baby.

Parents should avoid purchasing unregulated formulas from third-party websites or sellers. These products may not meet U.S. safety standards and could harm your baby’s health. Fortunately, there are a variety of safe, FDA-regulated formulas on the market.

“Many high-quality, evidence-based infant formulas are available in the U.S., including several that are either imported from Europe or reflect European nutritional standards,” Gillies says.

Whether using a traditional formula or one with a European-style approach, choosing an FDA-regulated product offers the peace of mind that comes with quality, safety and traceability.

“If formula is needed, we’re here to help families choose the option that best fits their baby’s needs,” Dr. Diab says. “All FDA-regulated formulas are safe and nutritionally complete, but every baby is different. If you're having trouble finding the right one, talk to your pediatrician or a nutrition expert at our clinic.”