Food Safety for 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.
Imported Infant Formula and Infant Formula Supplies
- Ongoing FDA Efforts to Increase Supply
- Resources for Parents and Caregivers on Imported Infant Formula
- Imported Infant Formula Names to Know
- Tips for Preparing Imported Infant Formula (Consejos para preparar la fórmula infantil importada)
- Infant Formula Supply Consumer Update
- Find Formula During the Infant Formula Shortage (HHS)
- Enforcement Discretion for Infant Formula
Food Safety & Nutrition from FDA
- Questions & Answers for Consumers Concerning Infant Formula
- Do's and Don'ts with Infant Formula
- What You Need to Know aout the Risk of Cronobacter in Powdered Infant Formula
- Help Prevent Cronobacter Illness: Prepare and Store Powdered Infant Formula Safely
- FDA Advises Parents and Caregivers to Not Make or Feed Homemade Infant Formula to Infants
- Food Safety Booklet for Pregnant Women, Their Unborn Babies, and Children Under Five
- Food Safety for Moms-To-Be - See Once Baby Arrives (Cuando llega el bebé)
- Advice about Eating Fish
- Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods
- What You Can Do to Limit Exposure to Arsenic
- What You Can Do to Limit Exposure to Arsenic and Lead from Juices
- To Help Protect Children from Environmental Contaminants, Healthy Food Choices for Your Baby Aged 6-12 Months
- Bottled Water Everywhere: Keeping It Safe
- FDA Regulates the Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages
- To Help Protect Children from Environmental Contaminants, Healthy Food Choices for Your Baby Aged 6-12 Months
- What You Can Do to Limit Exposure to Arsenic and Lead from Juices
- The Key to a Well-Balanced Diet is Eating a Variety of Healthy Foods
Alerts
- FDA Advises Parents and Caregivers Not to Buy or Give Mother’s Touch Formula to Infants (2022)
- FDA Investigation of Cronobacter Infections: Powdered Infant Formula (2022) (For additional information, see Powdered Infant Formula Recall: What to Know)
- Additional Safety Alerts
Industry Resources
- Infant Formula Guidance Documents & Regulatory Information
- Exempt Infant Formulas Marketed in the United States by Manufacturer and Category
- Enforcement Discretion for Infant Formula
Additional Resources
- Breastfeeding | NIH
- Children's Health | MEDLINEplus
- Choking | MEDLINEplus, (Atragantamiento)
- Women, Infants, and Children (WIC) | USDA - 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.
- Infant Formula: Evaluating the Safety of New Ingredients - Report from the Committee on the Evaluation of the Addition of Ingredients New to Infant Formula