Infant formula in 2026: Helping parents navigate the noise

Your first patient is a new parent worried that she’s feeding her baby the “wrong” formula. She’s read about heavy metals online, heard European formulas are cleaner, and wonders whether her infant’s gas and spit-up mean it’s time to switch formulas again. For many pediatricians, this scenario has become increasingly familiar. This article reviews the major categories of infant formula, explains current regulations and safety standards, and provides practical guidance for helping families navigate common concerns about infant formula.

Types of infant formula

While the number of infant formulas on the market continues to grow, most fall into a few predictable categories that pediatricians encounter regularly. For decades, standard cow’s milk–based formula has been the first-line recommendation for term infants. However, in 2023, both the FDA and AAP updated their guidance to include goat milk-based infant formula as an acceptable option.¹

Soy-based formulas may be useful for specific medical conditions, such as galactosemia, or temporarily following diarrheal illness with transient lactase deficiency. However, they should be avoided in premature infants weighing less than 1,800 grams.²

Hydrolyzed and amino acid–based formulas are designed for infants with cow’s milk protein allergy or malabsorption concerns.² In these formulas, proteins are broken down into smaller fragments, or fully into amino acids, to improve tolerance and reduce the likelihood of allergic reactions.

Other options, such as low-lactose or lactose-free formulas, are often marketed as “gentle” for gas, fussiness, or spit-up, though most infants do not require them. Premature formulas are a separate category, containing higher levels of calories, protein, calcium, and phosphorus to support catch-up growth in preterm infants.

Formula regulation and safety

It is a common misconception that infant formula is “FDA-approved.” While the FDA does not formally approve infant formulas, these products are heavily regulated to ensure they are safe and support normal growth and development. Before an infant formula can be legally marketed and sold in the United States, manufacturers must demonstrate that the product meets strict safety and nutritional standards. Ingredients must be GRAS-approved (Generally Recognized As Safe), formulas must contain 30 required nutrients within established ranges, and manufacturers must provide evidence that the formula supports normal infant growth in a clinical trial. Manufacturing facilities also undergo regular FDA inspections.³

The Infant Formula Act (IFA), originally passed in 1980 and updated several times since, established many of these standards and helped make infant formula one of the most highly regulated food products in the world. However, infant nutrition science continues to evolve. Current discussions include whether future updates should address ingredients such as DHA, probiotics, and human milk oligosaccharides, as well as nutrient requirements for premature infants.

Nutritional standards also vary internationally. For example, DHA is required in European formulas, whereas in the U.S. it is optional, though commonly included. In the European Union, infant formula composition is regulated by the European Commission and updated regularly based on emerging evidence.⁴

Imported formulas

Interest in imported formulas, often referred to as “boutique formulas,” surged following the 2022 formula shortage, which drastically changed how many families viewed formula safety and availability. In response to the widespread formula scarcity, the federal government launched Operation Fly Formula to transport specialty formula products from Europe into the United States.⁵

The shortage also introduced many families to European formulas for the first time. Even before 2022, parents were increasingly drawn to these products because of perceived differences in ingredients and regulatory standards. However, “different” does not necessarily mean safer or nutritionally superior. All infant formula legally sold in the United States, whether domestic or imported, must meet strict standards for safety and nutritional adequacy.

A bigger concern arises when families purchase imported formulas through third-party distributors or online retailers. These products may bypass standard U.S. oversight, creating potential issues related to storage, shipping, preparation instructions, and labeling.⁶

It is also important to note that some imported formulas may also have directions written in another language, use different scoop sizes, or follow different staging systems based on infant age. For example, many European formulas are divided into products for 0 to 6 months and 6 to 12 months, unlike standard U.S. formulas, which are generally designed for the entire first year of life. These differences can increase the risk of preparation errors or inappropriate formula selection if families are not counseled carefully. While European formulas may be well-regulated within their own systems, the most important factor is whether the product is obtained through safe, reliable, and regulated channels.

Parent concerns driving formula decisions

Many formula decisions today are not driven by clinical symptoms, but by ingredient concerns circulating online. Questions about heavy metals, seed oils, and corn syrup are increasingly common and often fueled more by fear-based messaging than evidence.

Heavy metals

In response to the shortages and increased public scrutiny, the FDA and Department of Health and Human Services launched Operation Stork Speed in 2025 to strengthen the U.S. formula supply and modernize oversight.⁷ This initiative includes expanded testing for contaminants such as lead, arsenic, cadmium, PFAS, and pesticides. Testing has shown that most infant formulas contain either undetectable or very low levels of contaminants.⁸ Even when substances such as lead or inorganic arsenic are detected, levels remain below safety thresholds established by both U.S. and European regulatory agencies. Importantly, trace exposure to environmental contaminants is not unique to formula; it is a broader food supply issue.

Seed oils

Seed oils are another common source of confusion online, often labeled as “inflammatory” or unsafe. In reality, nearly all infant formulas, including European formulas, contain blends of vegetable oils. These oils help mimic the fatty acid profile of breast milk and provide essential fatty acids needed for brain development, growth, and absorption of fat-soluble vitamins. Current evidence does not support avoiding seed oils in infant formula.

Corn syrup

Corn syrup is perhaps the most misunderstood ingredient in infant formula. Standard milk-based formulas primarily use lactose, similar to breast milk. However, reduced- or lactose-free formulas require an alternative carbohydrate source. In these cases, corn syrup solids are used as a source of glucose. Unlike high-fructose corn syrup, corn syrup solids used in infant formula do not contain fructose and are used to support infants with specific medical or digestive needs.

How to choose and when to change infant formula

With so many options available, it’s easy for both parents and clinicians to feel pressure to “optimize” formula choice. If an infant is feeding well and growing appropriately, there is usually no need to change formulas. Reassurance is often the most appropriate intervention, as most infants do well on standard formula. Many common concerns, such as spit-up, gas, or fussiness, are part of normal infant development and often improve with time rather than repeated formula changes. A different approach is warranted when red flag symptoms are present, including poor weight gain, blood in the stool, or significant feeding intolerance, which may prompt consideration of a specialty formula.

When a formula change is indicated, it is important to give the new formula time to work. Frequent switching, often driven by ongoing symptoms, parental anxiety, or social media advice, can make it difficult to determine what is helping. In most cases, a one- to two-week trial is reasonable before reassessing tolerance and response. Ultimately, the goal is not to find the “perfect” formula, but to identify one that supports growth, is well tolerated, and helps families feel confident in how they are feeding their infant.

References

1. Fuchs GJ, Abrams SA. Choosing a baby formula. American Academy of Pediatrics. October 20, 2023. Accessed May 15, 2026. https://www.healthychildren.org/English/ages-stages/baby/formula-feeding/Pages/cho osing-an-infant-formula.aspx

2. O'Connor NR. Infant formula. Am Fam Physician. 2009;79(7):565-570.

3. FDA Code of Federal Regulations. CFR Code of Federal Regulations Title 21. October 17, 2023. Accessed May 20, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=107.100

4. European Commission. Food for infants and young children. October 17, 2023. Accessed May 20, 2026. https://food.ec.europa.eu/food-safety/labelling-and-nutrition/specific-groups/food-infants-and-young-children_en

5. US Food and Drug Administration. Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies. Accessed May 6, 2026. https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/enforcement-discretion-manufacturers-increase-infant-formula-supplies.

6. Imdad A, Sherwani R, Wall K. Pediatric Formulas: An Update. Pediatr Rev. 2024;45(7):394-405. doi:10.1542/pir.2023-006002

7. US Food and Drug Administration. Operation Stork Speed. March 18, 2025. Accessed May 12, 2026. https://www.fda.gov/food/infant-formula-homepage/operation-stork-speed.