Operation Stork Speed
On March 18, 2025, the Department of Health and Human Services (HHS) and FDA announced Operation Stork Speed to expand options for safe, reliable, and nutritious infant formula for American families. This work builds upon the increased oversight activities FDA has implemented with regard to the infant formula industry since 2022 and supports the Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market.
Operation Stork Speed is a multi-pronged initiative that includes:
- Conducting the first comprehensive review of all infant formula nutrients since 1998;
- In May 2025, FDA issued a Request for Information (RFI) as a first step in the comprehensive nutrient review process. Following the close of the comment period on September 11, 2025, FDA is reviewing all feedback. Moving forward, FDA will evaluate available scientific evidence, including the feedback submitted through the RFI, to inform any decisions and next steps.
- Increasing testing of certain contaminants in infant formula and other foods children consume
- The FDA will continue to test infant formula products, including those new to the U.S. market, for contaminants both as a part of Operation Stork Speed and FDA’s routine food safety surveillance work. We are committed to sharing results with the public.
- The FDA continues to engage with infant formula manufacturers to discuss potential pathways contaminants may enter the supply chain including through ingredient sourcing and manufacturing processes as well as discuss measures to reduce the levels of these contaminants in infant formula to as low as possible.
- Increasing testing of infant formula and its ingredients for spore-forming microbiological contaminants, such as Clostridium botulinum and Bacillus cereus, to further inform risk reduction strategies. In February 2026, FDA initiated a sampling assignment focused on dairy-based ingredients, including whole milk powder, non-fat dry milk powder, and whey protein concentrate to evaluate the state of supply chain and inform next steps in the agency’s response to the 2025 infant botulism outbreak.
- Continuation of the personal importation policy for infant formula products, initially implemented in 2022.
- Encouraging companies to work with FDA on any questions regarding increased transparency and clearer labeling.
- The FDA continues to regularly meet with infant formula industry groups regarding proposed labeling of their products to benefit consumers.
- Communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients, health outcomes, and safety findings. In response to stakeholder feedback, FDA has developed a list of infant formulas on the US market. The FDA will continue to share information and updates with the public through agency announcements.
- Announcing in May 2025 the joint Nutrition Regulatory Science Program (NRSP) with NIH to investigate critical research questions about infant nutrition, including the role of maternal and infant dietary exposures on health outcomes across the lifespan.
- This research supports Operation Stork Speed by strengthening the scientific foundation necessary for evidence-based nutrient standards, improved safety testing protocols, and development of new infant formula products.
Through the strategic initiatives implemented under Operation Stork Speed, FDA continues to make strides to enhance the quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.
Identifying and Reporting a Problem
If you have concerns about infant formula, contact your health care provider and FDA at 1-888-INFO-FDA (1-888-463-6332). To report a complaint or adverse event (illness or serious allergic reaction), visit Industry and Consumer Assistance.