Infants & Toddlers

 

These Infants & Toddlers web pages contain information about infant formula that may be helpful to industry, consumers, government agencies, and other interested parties. They include the following:

• Information about FDA's regulation of commercial infant formulas

• Commonly asked questions about infant formulas

• Links to other relevant resources

• How to report problems

Requirements for infant formula are found in the Federal Food, Drug, and Cosmetic Act. All manufacturers of infant formula must begin with safe food ingredients, which are either generally recognized as safe (GRAS) or approved as food additives for use in infant formula.

Once an infant formula product is formulated, current laws require that the manufacturer must provide FDA assurance of the nutritional quality of that particular formulation before marketing the infant formula. FDA has provisions that include requirements for certain labeling, nutrient content, manufacturers quality control procedures (to assure the nutrient content of infant formulas), as well as company records and reports. FDA is also working to finalize a proposed rule for good manufacturing practice, quality control procedures, quality factors, notification requirements, and reports and records, for the production of infant formulas.

 

Information on Food Safety & Nutrition from FDA

• Questions & Answers for Consumers Concerning Infant Formula

• Investigation of Cronobacter Bacteria Illness in Infants December 30, 2011

• Health Information Advisory on Infant Formula October 1, 2008

  • News Release: FDA Issues Health Information Advisory on Infant Formula September 12, 2008

• Once Baby Arrives (also available in Spanish) August 24, 2005

• Exempt Infant Formulas Marketed in the United States By Manufacturer and Category

 

Information from Other Federal Government Agencies

• Centers for Disease Control and Prevention

  • Childhood Diseases

• Department of Health and Human Services Healthfinder

  • Infant Health

• National Institutes of Health

  • Breastfeeding

• National Library of Medicine

  • Children's Health (MEDLINEplus)

  • Choking (MEDLINEplus) (also available in Spanish)

• U.S. Department of Agriculture

  • Women, Infants, and Children (WIC)
    WIC provides Federal grants to States for supplemental foods, health care referrals, and nutrition education for low-income pregnant, breastfeeding, and non-breastfeeding postpartum women, and to infants and children up to age five who are found to be at nutritional risk.

• National Academy of Sciences

  • Infant Formula: Evaluating the Safety of New Ingredients 
    Report from the Committee on the Evaluation of the Addition of Ingredients New to Infant Formula