Original Constituent Update

May 16, 2022

Today the U.S. Food and Drug Administration (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, the FDA may determine that enforcement discretion is appropriate. In contrast, an infant formula containing less of a specific nutrient required 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 

• Guidance for Industry: Infant Formula Enforcement Discretion Policy
• Fact Sheet:  Helping Families Find Formula During the Infant Formula Shortage 
• Press Release: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability
• Questions & Answers for Consumers Concerning Infant Formula 
• FDA Advises Parents and Caregivers to Not Make or Feed Homemade Infant Formula to Infants
• FDA Investigation of Cronobacter Infections: Powdered Infant Formula