On March 28, 2023, the U.S. Food and Drug Administration released a national strategy outlining actions the agency will take immediately to help ensure one of the nation's most vulnerable populations continue to have access to safe, nutritious infant formula and to increase resiliency of the U.S. infant formula market and supply.

The Food and Drug Omnibus Reform Act of 2022 (FDORA) directed the FDA, in consultation with other federal government partners, to develop this immediate strategy to increase the resiliency of the U.S. infant formula market. Key elements of the immediate strategy released today include:

1) Ensuring industry is aware of requirements to develop and implement redundancy risk management plans. These plans are intended to help industry identify risks to the supply chains of infant formula and medical foods and to develop mitigation plans against potential disruptions that could impact production. 

2) Continuing to enhance inspections of infant formula manufacturers, including by expanding and improving infant formula training for investigators.

3) Expediting review of premarket submissions for new infant formula products to mitigate or prevent shortages.

4) Continuing to monitor the infant formula supply and developing a forecasting model to enable FDA to prepare for and mitigate future supply disruptions.

5) Engaging with U.S. government partners who play a role in mitigating other factors that may influence the infant formula supply, such as tariffs and market concentration, to sustain the safe, continuous production of infant formula.

6) Engaging with the U.S. Department of Agriculture to support efforts to build resiliency within its Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

7) Continuing to advance the agency's Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula.

8) Improving the agency's consumer education materials relating to infant formula on FDA.gov.

9) Enhancing and leveraging the FDA's partnerships with health care providers and professionals, particularly infant care professionals, to further expand the agency's consumer education program.