FDA Announces Release of Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market

🔹The U.S. Food and Drug Administration (FDA) released a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy builds on the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula MarketExternal Link Disclaimer which was released in early 2023 in direct response to the February 2022 infant formula recall and the subsequent shortage of infant formula in the U.S. The long-term strategy identifies the actions we have taken since 2023 and focuses on our long-term goal of achieving a more robust and nimble U.S. infant formula supply.

🔹In March 2023, the FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which collected observations, described immediate actions, and detailed short-term plans to improve the resiliency of the U.S. infant formula supply. Simultaneously, the FDA partnered with the National Academies of Sciences, Engineering and Medicine (NASEM), as directed by Congress, to further study challenges to the infant formula market in the U.S. in order to inform a long-term strategy. 

🔹In July 2024, NASEM produced a report titled Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United StatesExternal Link Disclaimer, which further emphasized the need for a multi-faceted approach to building resiliency into this important industry. The important lessons learned from both the immediate strategy and the NASEM report, as well as valuable insights from industry, healthcare professionals, consumer groups, regulatory partners, and other stakeholders on this issue have culminated in the development of this Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market.

🔹In the long-term strategy, we outline long-term actions to improve information-sharing across all stakeholder groups, as well as actions taken since 2023, to help protect the integrity of the infant formula supply chain. The long-term strategy also addresses implementing measures for preventing contamination, incentivizing new infant formula manufacturers to enter the U.S. market, as well as authorities needed to gain better insight into the supply chain and risk for shortages. Through this strategy, we aim to focus efforts on the areas where we have seen the largest impact, illustrate the accomplishments we have achieved in protecting this vital source of nutrition for our most vulnerable population, and highlight where more efforts are needed to continually improve the supply for years to come. The FDA is committed to working with all stakeholders to improve the resiliency of the infant formula supply and to ensure that consumers have the utmost confidence that the infant formula available in the U.S. is safe and nutritious.