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Companies Receiving Enforcement Discretion for Regular Infant Formula

Tips for Preparing Imported Infant Formula (Consejos para preparar la fórmula infantil importada) PDF

Resources for Parents and Caregivers on Imported Infant Formula 

*_{This infant formula is appropriate for most infants and meets U.S. nutrient requirements, but it may not be suitable for infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness. Parents and caregivers of infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness should check with their child’s health care provider to determine if this formula is appropriate for their child. Additional iron may be needed in these instances.}

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Companies Receiving Enforcement Discretion for Specialty Formulas for Infants with Special Medical Needs

Tips for Preparing Imported Infant Formula (Consejos para preparar la fórmula infantil importada) PDF

Resources for Parents and Caregivers on Imported Infant Formula

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On May 16, 2022, 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.  This action is designed to increase infant formula supplies in the United States while protecting the health of infants, for whom infant formula is often the sole source of nutrition during a critical period of growth and development.  The guidance will be in effect until November 14, 2022, and we will evaluate whether any extension is necessary.

The guidance is related to both the importation into the U.S. of infant formula produced in other countries and infant formula that is produced domestically.  It describes the information that infant formula manufacturers should provide to the FDA if they want to introduce into U.S. commerce infant formula that is safe and nutritionally adequate but may not comply with all FDA requirements.  The information sought includes a list of and amount of all nutrients as well as ingredients, a copy of the product label and description of packaging, current or anticipated inventory of the formula, microbiological testing results and facility inspection history. The FDA will use this information to consider on a case-by-case basis whether to exercise enforcement discretion.  For example, for an infant formula with a label that does not list the nutrients in the order required, but that otherwise meets applicable requirements, the FDA would likely determine that enforcement discretion is appropriate.  In contrast, an infant formula with meaningful differences in required nutrients might not be an appropriate candidate for enforcement discretion.  Certain labeling requirements, such as the clear identification of any allergens present in the product or adequate instructions for safe product preparation and use, are connected to food safety and will be considered carefully in evaluating requests for enforcement discretion.   

Among the requirements for infant formulas, the FDA regulations specify minimum amounts for 30 nutrients that must be included.  For 10 of these nutrients, there are maximum amounts as well.  In addition, any ingredient used in infant formula must be safe and suitable. The FDA also has specific requirements for labeling infant formulas.  They include directions for preparation and use, a pictogram showing the major steps for preparing infant formula and use by date.  

A voluntary recall by Abbott Nutrition in February 2022 and subsequent voluntary cease in production at their Sturgis facility, combined with the overall strains on supply chains experienced during the COVID-19 pandemic, have created concerns about the availability of certain types of infant formula. The FDA has already taken steps to support the increased supply of infant formulas, including regular meetings with infant formula manufactures to better understand their capacity to increase production and expediting review of notifications of manufacturing changes that will help increase supply—particularly of specialized formulas for medical needs such as metabolic disorders.

Requests for enforcement discretion should be sent to: 
infant_formula_flexibility@fda.hhs.gov.  

For More Information 

• Infant Formula Information and Ongoing FDA Efforts to Increase Supply
• Fact Sheet: Helping Families Find Formula During the Infant Formula Shortage 
• Outbreak Investigation: Cronobacter Infections - Powdered Infant Formula 2022
• Press Release: FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula June 22, 2022
• Press Release: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability May 16, 2022