Formulas (New)

Overview

While breast milk is recommended for infants in most situations for the first 6-12 months of life or longer, formula is often used in infancy when breast milk is not available or contraindicated. Formula is also given to older children who are unable to obtain adequate nutrition through conventional means. This page informs clinicians about different types and components of formulas used for premature infants, term infants, and toddlers and older children, indications for use of different types of formulas; and how to adjust caloric density as well as obtain funding for formula used by children with special health care needs.

Pearls and Alerts

  • When to stop preterm formula: Preterm infant formula and human milk fortifiers are designed to meet the increased vitamin and mineral needs of the preterm infant consuming smaller volumes than the term infant consumes. Continuation of the preterm infant formula and human milk fortifiers in infants who weigh more than 2.5-3.0 kg will result in increased intakes of several vitamins, including vitamins A and D. Case reports of hypervitaminosis D suggest that these products should be discontinued when the infant is exceeding the recommend intakes for fat-soluble vitamins.
  • Aluminum toxicity: Preterm infants and infants that were intrauterine growth restricted who use soy formula may be at risk of aluminum toxicity. [Fanni: 2014]

Formula Basics

Formula comes in 3 different forms:
  • Ready to feed (does not need to be prepared with water)
  • Powdered (must be mixed with water, but is the least expensive form)
  • Concentrated liquid
Delivery of formula can involve use of a cup, spoon, supplemental nursing system, bottle, or feeding tube (see Feeding Tubes and Gastrostomies). The nutritional content of formula is regulated by the U.S. Food & Drug Administration based on recommendations by the Committee on Nutrition (AAP). Nutritional requirements, digestive concerns, metabolic demands, and age of the child drive the selection of one formula over another. Background information on the many types of formulas available and detailed information about the different components of formula and the rationale for their use are presented below.
The links, below, lead to charts that list the major brands of formula and key differences among their ingredients.
First Year Weight Gain Goals (Birth-12 Months) for Term Infants
Age Grams/Day
0-3 months 25-30
3-6 months 15-20
6-12 months 10-15
Infants with increased energy needs, history of postnatal growth restriction, or feeding difficulties may continue on a higher caloric density feeding (24 kcal/oz). [Laili: 2010] After hospital discharge, it is unclear what represents optimal growth for the preterm infant. Growth data should be plotted according to the infant’s age corrected for prematurity.

Increasing Caloric Density - General Guide

Important recipes for increasing caloric density: When infants need extra calories to grow, the medical team can provide recipes for increasing the calories of 20 kcal/oz formulas ("term" formulas), or for 22 kcal/oz formulas (“preterm” formulas). Advise the caregiver to use precise measurements (i.e., a level scoop rather than rounded) to ensure consistent nutrition. Consult a dietician if unfamiliar with the nutritional and/or fluid requirements of your patient. If needed, contact a local NICU or children's hospital for advice. Cost and ease of home preparation must be considered.

Using Term Powder Formula to Increase Caloric Density
kcal/oz Add one scoop of 20 kcal/oz powder formula to:
20 60 mL or 2 oz of water
22 55 mL of water
24 50 mL of water
26 45 mL of water
27 42 mL of water
+ Due to variations in formula composition, it is best to consult the manufacturer's website for more details. Powder is less accurate than liquid concentrates. [American: 2013]

Using Preterm Powder Formula to Increase Caloric Density for Preterm Feeding Infants
kcal/oz Add one scoop of 22 kcal/oz premature infant powder formula to:
22 60 mL or 2 oz of water
24 55 mL of water
26 50 mL of water
27 48 mL of water
Adapted from How to Increase Calories (University of Michigan) (PDF Document 96 KB)
+ Due to variations in formula composition, it is best to consult the manufacturer's website for more details. Powder is less accurate than liquid concentrates. [American: 2013]

Do-It-Yourself Formulas

The American Academy of Pediatrics advises against making home-made infant formula due to serious risks of infection, ingredients that may be aspirated, and intolerance, as well as incomplete nutrition or excessive loads of certain ingredients that may be toxic. However, families may be very interested in learning more about this topic. One site with extensive information is Do-It-Yourself Baby Formulas, which is based on Weston A. Price Wise Traditions in Food, Farm, and the Healing Arts whole foods approach to diet. Many families of children with special health care needs also develop blenderized diets for tube feeding. These consist of taking a wholesome diet and blending it into a consistency which can be administered through a feeding tube. Consulting with a dietician is advised for families who which to pursue blenderized feeding instead of formula or in addition to formula use.

Formula Funding for Children with Chronic Conditions

Cost of formula preparations, which can vary greatly, should be considered when choosing a specific formula. Formulas are generally slightly cheaper if purchased through a home care company, commissary (if a parent is in the military), or warehouses (such as Costco or Sam's Club). Store brand and generic formulas offer more reasonably priced options and have to meet the same basic requirements as name brands do.
Some insurance companies have absolute exclusions regarding formulas, while others will pay for nutritional formulas only after infancy, or if the formula is needed for a special diet (e.g., malabsorption or PKU).
The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), for families with children under age 5, provides a limited selection of standard formulas in its formulary and requires a medical prescription with a valid diagnosis to provide alternative formulas. WIC does not necessarily cover all of the formula needed by infants, so caregivers may still be responsible for purchasing some.
Medicaid will usually fund formula if it is going through a feeding tube. Appeals may be necessary if the formula is being taken by mouth, or is not approaching 100% of the child's caloric needs. These appeals are often successful if the clinician writes a letter of medical necessity (see Tips for Writing a Letter of Medical Necessity (Rifton) and Writing Letters of Medical Necessity). Many formula companies offer sample letters of medical necessity for their specialized formulas. To aid in appealing an insurance company or Medicaid, it is helpful to demonstrate that the child cannot tolerate a cheaper formula first (e.g., try PediaSure first, if the child demonstrates intolerance, this information might help with the appeal for the more expensive hydrolyzed formula). Also, the diagnosis used to request the funding is important as Medicaid will not cover formulas for all diagnoses.
There are few mechanisms available to support those who fall between the cracks. Carnation Instant Breakfast or Ovaltine are examples of drink additives which can be a cheap alternative for the child who needs a caloric boost and added vitamins and minerals (although these products often add calories through sugar). A family can apply to Hospital Foundations or charity programs to help with costs, and a non-profit pharmacy may be able to provide formula at a non-profit rate. Technically, the public school system is required to supply the formula which is part of lunch (and breakfast if the child qualifies for the free breakfast program).

Brands of Formulas

Parents often ask their doctor for advice about brands. The links, below, lead to charts that list many brands of formula and key differences among their ingredients. The Medical Home Portal does not endorse a specific brand.
Although infant formulas are required to meet the requirements of the Infant Formula Act, manufacturers’ marketing claims often are not supported by clinical evidence or evaluated by the Food and Drug Administration. [Belamarich: 2015] FDA approval is only required for claims regarding formulas and their relationship to medical conditions; claims that do not reference conditions or disease (e.g., probiotics support digestive health) do not need FDA approval. [Abrams: 2015] Insufficient evidence shows that removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula generally benefits infants with fussiness, gas, or colic, [Thomas: 2010] [Sung: 2018] however ongoing research suggests that various combinations of these may provide benefit for certain conditions such as constipation and prevention of eczema.
Examples of store brands, most of which are manufactured by Perrigo Nutritionals, are:
  • Babies"R"Us
  • Berkley Jensen (BJ's)
  • Comforts for Baby (Kroger)
  • CVS Health
  • Kirkland Signature (Costco)
  • Meijer (Meijer Baby)
  • Member's Mark (Sam's Club)
  • Parent's Choice (Walmart)
  • Simply Right (Sam's Club)
  • Up & Up (Target)
  • Well Beginnings (Walgreens)

Resources

Information & Support

For Professionals

Primary Prevention of Allergic Disease Through Nutritional Interventions: Guidelines for Healthcare Professionals (AAAAI) (PDF Document 181 KB)
Information about food introduction and prevention of allergies and atopic dermatitis; American Academy of Allergy Asthma and Immunology.

Probiotics and Prebiotics in Children (AAP)
Reviews the currently known health benefits of probiotic and prebiotic products, including those added to commercially available infant formula and other food products for use in children; American Academy of Pediatrics.

Myotomal chart

For Parents and Patients

Support

Kids with Food Allergies (AAFA)
Provides education and an online support community for children with food allergies; a Division of the Asthma and Allergy Foundation of America.

General

Nutrient Requirements for Formula (USGS)
Provides a chart of infant formula nutrients based on the Code of Federal Regulations Title 21 Part 107; United States Federal Government.

Practice Guidelines

Fleischer DM, Spergel JM, Assa’ad AH, Pongracic JA.
Primary Prevention of Allergic Disease Through Nutritional Interventions: Guidelines for Healthcare Professionals.
American Academy of Allergy Asthma & Immunology. 1:29-36; 2013. / http://medical.gerber.com/docs/default-source/pdfs/aaaai-physician-ref...

Sampson HA, Aceves S, Bock SA, James J, Jones S, Lang D, Nadeau K, Nowak-Wegrzyn A, Oppenheimer J, Perry TT, Randolph C, Sicherer SH, Simon RA, Vickery BP, Wood R, Bernstein D, Blessing-Moore J, Khan D, Lang D, Nicklas R, Oppenheimer J, Portnoy J, Randolph C, Schuller D, Spector S, Tilles SA, Wallace D, Sampson HA, Aceves S, Bock SA, James J, Jones S, Lang D, Nadeau K, Nowak-Wegrzyn A, Oppenheimer J, Perry TT, Randolph C, Sicherer SH, Simon RA, Vickery BP, Wood R.
Food allergy: a practice parameter update-2014.
J Allergy Clin Immunol. 2014;134(5):1016-25.e43. PubMed abstract

Tools

Fluid Calculator for Children (Medscape)
Calculates typical daily and hourly fluid requirements (mL) per weight of the child.

Formulas and Fortifiers for Premature and Low Birth Weight Infants (PDF Document 94 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal, last updated December 2015.

Formulas for Term Infants (PDF Document 125 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal, last updated December 2015.

Formulas for Toddlers & Older Children (PDF Document 168 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal, last updated December 2015.

Nutrition Issues and Concerns (Bright Futures) (PDF Document 1.8 MB)
A Table of Selected Energy Calculations for Children and Adolescents with Special Healthcare Needs for down syndrome, spina bifida, Prader-Willi syndrome, cystic fibrosis, and pediatric HIV infection is on page 125; American Academy of Pediatrics.

Services

Developmental Pediatrics

See all Developmental Pediatrics services providers (25) in our database.

Food Assistance

See all Food Assistance services providers (6) in our database.

Nutrition Assessment Services

See all Nutrition Assessment Services services providers (3) in our database.

Nutrition, Metabolic

See all Nutrition, Metabolic services providers (2) in our database.

Pediatric Gastroenterology

See all Pediatric Gastroenterology services providers (16) in our database.

WIC Clinics

See all WIC Clinics services providers (10) in our database.

For other services related to this condition, browse our Services categories or search our database.

Helpful Articles

Hojsak I, Bronsky J, Campoy C, Domellöf M, Embleton N, Fidler Mis N, Hulst J, Indrio F, Lapillonne A, Mølgaard C, Vora R, Fewtrell M.
Young Child Formula: A Position Paper by the ESPGHAN Committee on Nutrition.
J Pediatr Gastroenterol Nutr. 2018;66(1):177-185. PubMed abstract

Martin CR, Ling PR, Blackburn GL.
Review of Infant Feeding: Key Features of Breast Milk and Infant Formula.
Nutrients. 2016;8(5). PubMed abstract / Full Text

Molska A, Gutowska I, Baranowska-Bosiacka I, Noceń I, Chlubek D.
The content of elements in infant formulas and drinks against mineral requirements of children.
Biol Trace Elem Res. 2014;158(3):422-7. PubMed abstract / Full Text

Chung CS, Yamini S, Trumbo PR.
FDA's health claim review: whey-protein partially hydrolyzed infant formula and atopic dermatitis.
Pediatrics. 2012;130(2):e408-14. PubMed abstract

Jatinder Bhatia, MD, Frank Greer, MD.
Use of Soy Protein-Based Formulas in Infant Feeding.
Pediatrics. 2008;121(5). / Full Text

Koletzko B, Baker S, Cleghorn G, Neto UF, Gopalan S, Hernell O, Hock QS, Jirapinyo P, Lonnerdal B, Pencharz P, Pzyrembel H, Ramirez-Mayans J, Shamir R, Turck D, Yamashiro Y, Zong-Yi D.
Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group.
J Pediatr Gastroenterol Nutr. 2005;41(5):584-99. PubMed abstract

Kumar M, Kabra NS, Paes B.
Carnitine supplementation for preterm infants with recurrent apnea.
Cochrane Database Syst Rev. 2004(4):CD004497. PubMed abstract

Laili Abd Latif, M et al.
Nutrition Interventions for Children with Special Health Care Needs.
2010; 3rd:441. Washington: Washington Department of State Health; http://here.doh.wa.gov/materials/nutrition-interventions/15_CSHCN-NI_E...

National Institutes of Health.
Infant Formulas.
U.S. National Library of Medicine; (2015) http://www.nlm.nih.gov/medlineplus/ency/article/002447.htm. Accessed on Dec. 2016.

Singhal A, Kennedy K, Lanigan J, Clough H, Jenkins W, Elias-Jones A, Stephenson T, Dudek P, Lucas A.
Dietary nucleotides and early growth in formula-fed infants: a randomized controlled trial.
Pediatrics. 2010;126(4):e946-53. PubMed abstract

Verner A, Craig S, McGuire W.
Effect of taurine supplementation on growth and development in preterm or low birth weight infants.
Cochrane Database Syst Rev. 2007(4):CD006072. PubMed abstract

Authors

Content Last Updated: 6/2018

Page Bibliography

Abrams SA.
Is it time to put a moratorium on new infant formulas that are not adequately investigated?.
J Pediatr. 2015;166(3):756-60. PubMed abstract

American Academy of Pediatrics Committee on Nutrition; Editor in chief: Ronald E. Kleinman, MD, FAAP; Associate editor: Frank R. Greer, MD, FAAP .
Pediatric Nutrition.
7th ed. Elk Grove Village. IL: American Academy of Pediatrics; 2013. 978-1-58110-816-3 http://shop.aap.org/Pediatric-Nutrition-7th-Edition-Paperback/

Belamarich PF, Bochner RE, Racine AD.
A Critical Review of the Marketing Claims of Infant Formula Products in the United States.
Clin Pediatr (Phila). 2015. PubMed abstract

Fanni D, Ambu R, Gerosa C, Nemolato S, Iacovidou N, Van Eyken P, Fanos V, Zaffanello M, Faa G.
Aluminum exposure and toxicity in neonates: a practical guide to halt aluminum overload in the prenatal and perinatal periods.
World J Pediatr. 2014;10(2):101-7. PubMed abstract

Sung V, D'Amico F, Cabana MD, Chau K, Koren G, Savino F, Szajewska H, Deshpande G, Dupont C, Indrio F, Mentula S, Partty A, Tancredi D.
Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis.
Pediatrics. 2018;141(1). PubMed abstract

Thomas DW, Greer FR.
Probiotics and prebiotics in pediatrics.
Pediatrics. 2010;126(6):1217-31. PubMed abstract / Full Text