The FDA is taking additional steps to increase infant formula supplies. The FDA issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula.
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 Imported Infant Formula and Infant Formula Supplies
- Infant Formula Information and Ongoing FDA Efforts to Increase Supply
- Tips for Preparing Imported Infant Formula
Consejos para preparar la fórmula infantil importada
- Resources for Parents and Caregivers on Imported Infant Formula
- Companies Receiving Enforcement Discretion for Regular Infant Formula
Information on Food Safety & Nutrition from FDA
- Help Prevent Cronobacter Illness: Prepare and Store Powdered Infant Formula Safely
- 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)
- Infant Formula: Safety Do's and Don'ts
- Questions & Answers for Consumers Concerning Infant Formula
- FDA Advises Parents and Caregivers to Not Make or Feed Homemade Infant Formula to Infants
- Exempt Infant Formulas Marketed in the United States by Manufacturer and Category
- 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