Infant Formula Ingredients and Components

Insights into the implications of different formula components, including their indicated uses

Formulas are made of 6 basic components – protein, fat, carbohydrate, vitamins, minerals, and other nutrients such as probiotics and prebiotics. What makes one brand of formula different from the next is the specific combination of carbohydrates, fats, and proteins it uses, as well as any additional ingredients. These differences and their indicated use are explained below. Topical Reviews in Pediatrics (TRIP) does not endorse a specific brand or preparation; however, commercially prepared formulas will be mentioned here to provide examples.

Key Points

Classification of formulas
There are many different commercially available formulas, which are generally classified by the type of protein they contain.

Home-made formula is not advised
Home-made formula is not recommended due to the risk of infection and the infant’s need for a specific combination of nutrients and ingredients. Reports of failure to thrive, malnutrition, and vitamin/mineral deficiencies have been documented with home-made formula use.  

Pre-term vs. term infant formulas
All formulas for term infants generally contain similar amounts of protein, fat, carbohydrates, vitamins, and minerals, and are usually 20 kcal/oz. Formulas for preterm infants may have higher amounts of protein and certain vitamins/minerals. When mixed according to package directions, they are typically higher in calorie density at 22 kcal/oz.

Guidelines

Global standard for the composition of infant formula: Recommendations of an ESPGHAN coordinated international expert group. Koletzko, B., Baker, S., Cleghorn, G., Neto, U. F., Gopalan, S., Hernell, O., Hock, Q. S., Jirapinyo, P., Lonnerdal, B., Pencharz, P., Pzyrembel, H., Ramirez-Mayans, J., Shamir, R., Turck, D., Yamashiro, Y., & Zong-Yi, D. (2005). Journal of Pediatric Gastroenterology and Nutrition, 41(5), 584–599.

Protein

Formulas are commonly differentiated by the type of proteins they contain. These include cow’s milk protein, soy protein, goat’s milk protein, partially hydrolyzed, extensively hydrolyzed, and amino acid-based formulas. Common conceptions about the benefits of these different proteins are often not well grounded by evidence. Additional research into other mammalian and plant-based proteins (e.g., goat and rice) is underway (Maryniak et al., 2022; Vandenplas et al., 2021).

Cow’s milk protein.  Protein from cow’s milk includes whey and casein. While whey and casein are also in human milk, there are differences between the whey in human milk and the whey in cow’s milk. Protein content of cow’s milk-based formulas tends to be higher than in human milk and can result in increased amino acid levels (of unclear clinical significance) (Kleinman & Greer 2019).

• Indications for use: Typically, first-line replacement for breastmilk/donor milk.
• Contraindications: Cow’s milk protein allergy/intolerance and certain metabolic conditions including galactosemia.
• Examples: Enfamil Infant, Similac Infant, store brand Advantage, or Infant Premium.

Soy protein. While many people think that soy formulas are an appropriate substitute for cow’s milk formulas, approximately 10-14% of infants with an allergy to cow’s milk protein also have an allergy to soy protein (Kleinman and Greer, 2019). There have been theoretical concerns about high levels of dietary soy isoflavones adversely affecting human development, reproduction, or endocrine function, but the current evidence does not demonstrate these negative outcomes (Vandenplas et al., 2021).

• Indications for use: Galactosemia, hereditary lactase deficiency, IgE-mediated allergy to cow’s milk, vegan, secondary lactose intolerance related to acute gastroenteritis. Soy formula has not been shown to prevent or manage colic or atopic disease or treat cow’s milk allergy (CMA) symptoms (Vandenplas et al., 2021).
• Contraindications: Not designed or recommended for preterm infants who weigh <1800 g due to increased risk of osteopenia with calcium and phosphorus binding (Kleinman & Greer, 2019). Some older guidelines recommend avoidance of soy formula until 6 months due to risk of allergies, but the evidence is lacking (Katz et al., 2014). Avoid in infants with proctitis or enterocolitis.
• Examples: Enfamil ProsoBee, Gerber Good Start Soy, Similac Soy Isomil.

Goat’s milk protein. Goat milk formulas are becoming increasingly popular, especially since receiving approval from the American Academy of Pediatrics (AAP) in 2023 after the formula shortage in the US. These formulas are nutritionally complete, and many parents report improved gastrointestinal tolerance and better stooling with their use (Brown, 2024).

• Indications for use: Family preference, gastrointestinal comfort
• Examples: Kabrita, Kedamil, Holle, Hipp.

Partially hydrolyzed protein. Cow’s milk proteins (whey and/or casein) are broken into portions, making them somewhat easier to digest. Partially hydrolyzed infant formulas are not considered “hypoallergenic” by the FDA (Chung et al., 2012). In many infants with cow’s milk protein allergy, partially hydrolyzed formula may be well-tolerated and more palatable than extensively hydrolyzed formula, but due to the potential for cross-reactivity, extensively hydrolyzed formulas should be used for initial management of suspected CMA (Kido et al., 2015; Vandenplas et al., 2021).

• Indications for use: May be tolerated by some infants with cow’s milk protein intolerance. Insufficient evidence for use in prevention of asthma, eczema, food allergies, and rhinitis, although possibly helpful to prevent eczema in infants at high risk (Cabana, 2017; Vandenplas & Salvatore, 2016).  Insufficient evidence for use to manage gastroesophageal reflux, constipation, colic, or CMA in infants (Vandenplas & Salvatore, 2016; Savino et al., 2014).
• Contraindications: Milk allergy (Chung et al., 2012).
• Examples: Similac Total Comfort, Enfamil Gentlease, Gerber Good Start products, and store-brand Gentle or Comfort formulas.

Extensively hydrolyzed protein. Through a heat and enzymatic process, casein is broken into small portions (peptides and amino acids), which are then generally not recognized by the body as an allergen. Taste and cost can be a limiting factor for use.

• Indications for use: Infants diagnosed with CMA, an allergy to cow’s milk protein with significant protein-induced enteropathy or enterocolitis (Chung et al., 2012) or failure to thrive (Mousan & Kamat, 2016). Weak evidence for use in prevention of allergies (Lifschitz & Szajewska, 2015; Vandenplas et al., 2014). Lack of evidence for use in preventing asthma and allergic rhinitis, although possibly helpful to prevent eczema in infants at high risk (Cabana, 2017; Vandenplas & Salvatore, 2016).  These formulas may help to manage symptoms of gastroesophageal reflux when some degree of cow’s milk protein is present (Eichenwald et al., 2018) There is insufficient evidence for constipation or colic in term infants (Savino et al., 2014; Vandenplas & Salvatore, 2016) and lack of evidence to prevent necrotizing enterocolitis or feeding intolerance in preterm infants (Ng et al., 2017).
• Examples: Similac Alimentum, Gerber Extensively HA, Enfamil Nutramigen.

Hydrolyzed rice-based formulas: There is an international consensus guideline for CMA and research indicating that rice-based extensively hydrolyzed formula is an appropriate alternative to these better-known extensively hydrolyzed formulas. May not be widely available in the US.

• Indications for use: Cow’s milk allergy
• Examples: Novalac Allergy.

Amino acid-based protein (aka Elemental). Taste and cost can be a limiting factor for use.

• Indications for use: When extensively hydrolyzed formulas are not tolerated and there is extreme protein hypersensitivity or anaphylaxis to cow’s milk protein (Meyer et al., 2018; Mousan & Kamat, 2016). May be used for severe enteropathy, including severe rectal bleeding, growth failure, and eosinophilic esophagitis, particularly for those infants with multiple symptoms (Meyer et al., 2018).
• Examples: Alfamino, EleCare, Neocate, PurAmino.

Peptide formulas for infants >1 year of age. Small chains of amino acids may be easier to digest in certain medical conditions.

• Indications for use:  For enteral use/tube feeding for patients with impaired gastrointestinal function.
• Examples: Kate Farms Pediatric Peptide formulas, Peptamen Jr, Pediasure Peptide based formula.

Fat

Typically, almost half of the calories in cow’s milk-based formulas are from fat that is formulated to provide an appropriate and absorbable blend of essential fatty acids. The fat is usually derived from vegetable oils such as palm olein, soy, coconut, high-oleic sunflower or safflower, plus occasionally animal fats (Kleinman & Greer, 2019). Many formulas include added long-chain poly-unsaturated ARA and DHA omega fatty acids. The sources of these are single-cell organisms.

Medium-chain triglycerides. More readily digestible than long chain.

• Indications for use: For fat malabsorption, such as in short bowel syndrome, cystic fibrosis, and intractable diarrhea.
• Examples: Pregestimil – this formula is not currently on the market. Mead Johnson stopped production of the powdered formula during the 2022 formula shortage, and the company is unsure when production will resume. For increased MCT oil, could consider Enfaport or Monogen, though these formulas are typically used for lymphatic disorders, such as chylothorax. 

Long-chain triglycerides (ketogenic). Provides 3-4 grams of fat for every 1 gram of carbohydrate and protein.

• Indications for use: For children whose seizures have not responded to several different seizure medicines: Only for use in close consultation with a neurologist (Kossoff, 2017). 
• Examples: Nutricia KetoCal.

Polyunsaturated fatty acids (PUFAs). Added to emulate the composition of breast milk, but may lead to deterioration of the product unless antioxidants are added (Zou et al., 2016).

• Indications for use: Lack of evidence currently that adding PUFAs helps prevent allergies (Schindler et al., 2016). Insufficient evidence of the risks or benefits of using PUFAs for preterm infants for visual acuity, growth, and neurodevelopment (Moon et al., 2016). A recent study showed modest neurodevelopmental improvement scores at 5 years of age when preterm born before 29 weeks were supplemented with DHA (Gould et al., 2022).
• Examples: DHA (docosahexaenoic acid) and ARA (arachidonic acid).

Carbohydrate

Lactose is the main carbohydrate in human milk and in many formulas. It breaks down to glucose and galactose. Almost all infants can tolerate lactose, even when they have cow’s milk protein allergy (Heine et al., 2017).  Corn maltodextrin is sometimes used as a secondary source of carbohydrate in formula. One study found that many infant formulas’ calories are more than 20% from sugar (Walker & Goran, 2015). Complex carbohydrates, also known as starches, are used in some formulas as thickeners to help with gastroesophageal reflux.

Alternatives to lactose. These include sucrose, corn syrups, tapioca starch, maltodextrins, and other modified starches. Reduced lactose formulas exist as well.

• Indications for use: Galactosemia or congenital lactase deficiency, which is rare, and lactose intolerance (not a common infant condition). Infants with Neonatal Opioid Withdrawal Syndrome (NOWS) or Neonatal Abstinence Syndrome (NAS) can experience lactase deficiency, and these formulas may improve gastrointestinal tolerance (less emesis and loose stools) during the withdrawal period, though breastmilk always is preferred when available.
• Examples of lactose-free formulas: Enfamil ProSobee, Gerber Good Start Soy, Similac Soy Isomil, store brand Soy.
• Examples of reduced-lactose formulas: Gerber Good Start Soothe, Enfamil Sensitive, Similac Sensitive, Similac Total Comfort, store brand Sensitivity.

Added starch. Typically contains added rice starch

• Indications for use: Gastroesophageal reflux.
• Examples: Enfamil A.R., Similac for Spit-Up, store brand Added Rice Starch.

Electrolytes, Minerals, and Vitamins

These include major and trace (FDA-regulated) minerals and vitamins. Minerals, such as iron and aluminum (below), as well as sodium, potassium, chloride, calcium, magnesium, phosphorous, zinc, and more may be included. Formulas also include vitamins A, D, E, K, and water-soluble vitamins including B vitamins, folate, vitamin C, and biotin.

Iron: Quantities vary in different types of formulas to adjust for absorption. Standard infant formulas contain 10-12 mg/L. Low-iron formulas contain 4-6 mg/L and are not routinely recommended. European formulas, which are becoming more common after formula shortages in the U.S., are typically lower in iron. Caregivers may be concerned that the iron upsets their infant’s stomach or causes constipation, but no scientific evidence demonstrates this effect (Kleinman & Greer, 2019).

• Indications for use of low-iron formulas: Neonatal hemochromatosis (rare), impaired renal function.
• Example: Similac PM 60/40.

Aluminum: Although the aluminum content of human milk is 4-65 ng/mL, soy protein-based formula is 600-1300 ng/mL (Bhatia et al., 2008). Because aluminum competes with calcium for absorption, increased amounts of dietary aluminum from isolated soy protein-based formula may contribute to the reduced skeletal mineralization (osteopenia) observed in preterm infants and infants with intrauterine growth retardation (Bhatia et al., 2008). Term infants with normal renal function do not seem to be at substantial risk of developing aluminum toxicity from soy protein-based formulas (Bhatia et al., 2008). 

Other Nutrients

Emerging research on formulas using combinations of interventions, including synbiotic (both probiotics and prebiotics), low-lactose content, hydrolyzed proteins, magnesium, and/or other components, suggests opportunities for improvement of infant colic, spitting up, constipation, allergies, and intestinal health as well as potential health benefits for premature infants, such as prevention of necrotizing enterocolitis. However, the FDA issued a warning in 2023 about probiotic use in NICUs due concern for bacterial and yeast infections (Food and Drug Administration, 2023).

Currently in the United States, probiotic use has halted in NICUs. Additional components added to infant formula to more closely emulate breast milk may include taurine (Verner et al., 2007), lutein, choline, carnitine (Kumar et al., 2004), nucleotides (Singhal et al., 2010), Vitamin E, and others.

Probiotics: Probiotics are supplements containing organisms that change the microflora of the host. These organisms are typically Lactobacillus, Bifidobacterium, and Streptococcus species. The addition of probiotics to powdered infant formula has not been proven harmful to healthy term infants. A 2018 AAP meta-analysis supports use of Lactobacillus reuteri to treat infant colic in breast-fed babies, but the evidence is still lacking for its use in formula (Sung et al., 2018).

• Examples of Formulas Containing Probiotics: Gerber Good Start, Good Start Gentle, Good Start Grow for Toddlers, and Pure Bliss by Similac.

Prebiotics: Prebiotics are supplements containing a nondigestible ingredient, usually in the form of oligosaccharides, which selectively stimulate the favorable growth or activity of indigenous probiotic bacteria. Human milk contains substantial quantities of prebiotics. Use of prebiotics in infant formula is undergoing extensive study but is not thought to be harmful (Vandenplas et al., 2017). 

• Examples: Almost all infant formulas and many older child formulas include prebiotics.

Toxins

Increasing attention is paid to contaminants in formula and infant foods, including arsenic, cadmium, lead, mercury, and others. The water used to prepare formula can also be contaminated. There have been concerns with arsenic exposure and rice cereal. Clinicians can counsel families on reducing risk through the use of lead-free tap water in formula preparation and other food preparation tips.

Referrals

• Nutrition Assessment Services
• WIC Assistance

Patient Education

• Choosing an Infant Formula (Bright Futures)
• Six Tips to Reduce Babies’ Heavy Metal Exposure (Bright Futures)
  

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Article History

Previously, this article was published by the Medical Home Portal. The Medical Home Portal, retired in July 2024, provided diagnosis and management information for pediatric conditions, guidance for immediate steps after a positive newborn screen result, and in-depth family education to improve outcomes for children with complex medical care needs. The full archive can be found at the Medical Home Portal Archive. 

Topical Reviews in Pediatrics (TRIP) includes archival and updated content from the Medical Home Portal and features new, contemporary topics in pediatrics.  

• 2018 first publication: Jennifer Goldman, MD, MRP, FAAP ^A

^AAuthor; ^CAContributing Author; ^SASenior Author; ^RReviewer