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
- Questions & Answers for Consumers Concerning Infant Formula
- Once Baby Arrives (also available in Spanish)
- Exempt Infant Formulas Marketed in the United States By Manufacturer and Category
- Department of Health and Human Services HealthfinderInfant Health
- National Institutes of Health: Breastfeeding
- Children's Health (MEDLINEplus)
- Choking (MEDLINEplus) (also available in Spanish)
- 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.
- Evaluating the Safety of New Ingredients in Infant Formula - Report from the Committee on the Evaluation of the Addition of Ingredients New to Infant Formula