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On March 18, 2025, the U.S. Department of Health and Human Services (HHS) announced that it would lead the Food and Drug Administration (FDA) in implementing new measures to enhance the quality, safety, nutritional adequacy, and supply resilience of infant formula in the United States.
HHS introduced these initiatives under the name "Operation Stork Speed", which aims to ensure that infant formula remains a safe and reliable source of nutrition for American families. The FDA's key actions include:
1. Nutrient Review Process
The FDA will initiate a legal requirement for a comprehensive review of infant formula nutrients. A Request for Information will be issued in the coming months to begin the first major update since 1998.
2. Enhanced Contaminant Testing
The FDA will increase testing for heavy metals and other contaminants in infant formula and related foods consumed by children.
3. Expansion of Importation Policies
The FDA will extend its personal importation policy to facilitate a broader range of high-quality infant formula options.
4. Industry Collaboration on Labeling
Manufacturers are encouraged to work with the FDA to improve transparency and ensure clearer labeling for consumers.
5. Ongoing Consumer and Stakeholder Communication
The FDA will maintain regular communication with consumers and industry stakeholders to provide updates on regulations and scientific findings related to formula ingredients and health outcomes.
6. Scientific Research Collaboration
The FDA will collaborate with the National Institutes of Health (NIH) and other scientific organizations to address priority research gaps on the short- and long-term health impacts of infant formula feeding.
Previously, in 2022, the United States experienced a severe infant formula shortage due to the shutdown of an Abbott facility following product recalls and safety concerns, leading to supply disruptions. The newly introduced measures aim to prevent similar crises in the future and strengthen the infant formula supply chain.
ChemLinked Suggestions
Overseas manufacturers are advised to align with FDA nutritional standards, especially in preparation for the upcoming nutrient review process. To address the FDA’s enhanced focus on contaminant monitoring, companies should implement rigorous safety testing for heavy metals and other potential contaminants. These measures will help manufacturers navigate regulatory changes and strengthen their position in the U.S. market.
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