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Infant Formula Homepage

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Infant formula is an important source of nutrition for many babies in the U.S., whether used exclusively or in combination with breastfeeding. Although breastfeeding is recommended as the optimal choice of nutrition for most infants, many infants in the U.S. rely on infant formula for some or all of their nutrition. Ensuring that the youngest and most vulnerable individuals have access to safe and nutritionally adequate infant formula is a top priority for FDA.    

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How the FDA Oversees the Safety and Nutritional Quality of Infant Formula? 

The FDA regulates the production of infant formulas to help ensure that these products are safe and support healthy growth in infants who consume them. The FDA’s highly trained staff of dietitians, doctors, scientists, and food safety experts review the safety, nutritional adequacy, packaging, and labeling of infant formula products sold in the U.S.  

Notification Process

  • The FDA does not approve infant formulas. However, infant formula manufacturers must notify FDA before marketing a new formula in the United States by providing FDA with a new infant formula submission. The notification review process ensures that all products meet required nutritional and safety requirements. If an infant formula product is sold in the U.S. and does not meet all applicable requirements, FDA has the authority to take steps to remove it from the market to protect the health of infant consumers.

Infant Formula Requirements

  • Nutrients and Ingredients: The FDA regulations specify 30 nutrients that must be included in any infant formula sold in the United States. New infant formulas are reviewed to ensure they contain adequate protein and support healthy growth in infants. The FDA also requires that all ingredients used in infant formula be approved food additives or generally recognized as safe (GRAS) and suitable for such use. The FDA routinely evaluates individual nutrients to ensure infants receive optimal nutrition based on the most current scientific evidence.
  • Safety: Infant formula manufacturers must follow sanitary controls that are required by federal law to prevent contamination of infant formula during manufacturing. For example, infant formula manufacturers must establish a system of controls designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula. Further, FDA regulations require testing in infant formula for the pathogens Salmonella and Cronobacter. FDA regulations require that the water the companies use to manufacture formulas meets safety standards set by the U.S. Environmental Protection Agency.
  • Inspections: The FDA inspects facilities that make infant formulas annually and carefully trains its investigators to ensure that every infant formula inspection is robust, thorough, and focused on the most critical aspects of the infant formula manufacturing process.
  • Labeling: The FDA has specific requirements for infant formula labels. Information on infant formula labels that is most helpful for caregivers of infants includes directions for preparation and use, a pictogram showing the major steps for preparing infant formula, and a “use by” date. Labels are also required to provide information that is truthful and not misleading.  
  • Imported Formula: All infant formula products sold in the U.S., whether produced domestically or imported, must meet all U.S. requirements, including those for safety and nutritional adequacy. Caregivers should use caution when ordering imported infant formula products online or from third party distributors because these products may not meet U.S. requirements for safety and/or nutritional adequacy.
     

Identifying and Reporting a Problem

If you have concerns about infant formula, contact your health care provider and the FDA at 1-888-INFO-FDA (1-888-463-6332). To report a complaint or adverse event (illness or serious allergic reaction), visit Industry and Consumer Assistance.

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