New science-based roadmap focuses on understanding contamination risks and strengthening safety across the infant formula supply chain
Washington, 11 September 2026 – Infant formula safety is receiving renewed attention as food safety experts, manufacturers and researchers work to better understand emerging risks in powdered formula. A new report from the Reagan Udall Foundation for the FDA is offering a science-based roadmap for identifying and reducing the risk of Clostridium botulinum spores in infant formula.
The International Dairy Foods Association, or IDFA, has welcomed the report and plans to support continued work with industry, researchers and other stakeholders. The report follows a roundtable held in July that brought together representatives from the infant formula industry, the U.S. Food and Drug Administration, academic institutions and consumer advocacy groups.
Understanding the Risk
Clostridium botulinum is a bacterium that can produce toxins responsible for botulism, a serious illness. The new focus on its spores in powdered infant formula comes after recent infant botulism events raised questions about how these spores could enter the formula supply chain.
Researchers and industry experts are now looking more closely at where the spores may be found, how they could move through the supply chain and which measures could reduce the risk.
One of the report’s main recommendations is to establish better data on the presence of C. botulinum spores. At present, there is not enough information to clearly determine where spores may enter or become concentrated, from agricultural production and ingredient processing to the manufacturing of finished powdered infant formula.
The Supply Chain Matters
Infant formula passes through several stages before reaching families. Ingredients can come from different suppliers and undergo multiple processing steps, making supply chain oversight an important part of food safety.
The FDA has also emphasized the need for infant formula manufacturers to understand their suppliers, including where ingredients originate, how they are produced and what potential risks they may carry. The agency has called for stronger supplier oversight and faster action when safety concerns are identified.
The new report therefore takes a broader approach. Instead of focusing only on the finished product, researchers are being encouraged to study the entire supply chain. This could help identify points where contamination risks can be reduced most effectively.
Research to Guide Action
The next phase of work will involve collecting more information and developing reliable scientific evidence. IDFA said it will continue participating in the Cornell Pathogenic Spore Consortium, which brings together infant formula manufacturers, dairy ingredient suppliers and researchers.
Establishing baseline data is considered an important first step. Once researchers have a clearer picture of how frequently spores occur and where they are most likely to appear, manufacturers and regulators can better determine which controls and prevention measures are needed.
The goal is not simply to collect more data. It is to use that information to develop practical safety measures that can be applied across the infant formula supply chain.
Technology and Testing
Testing is becoming an increasingly important part of infant formula safety. The FDA has expanded its testing activities to examine both chemical contaminants and spore forming microorganisms. Its broader infant formula safety efforts include testing for substances such as lead, mercury, cadmium, arsenic and PFAS, as well as microorganisms such as C. botulinum and Bacillus cereus.
These efforts are designed to provide a clearer understanding of potential hazards while helping manufacturers strengthen preventive controls.
A Collaborative Approach
The report highlights the importance of cooperation among manufacturers, ingredient suppliers, scientists and regulators. Infant formula safety involves multiple stages and organizations, meaning improvements in one area may not be enough on their own.
For the industry, the roadmap provides a framework for continued research and evidence based decision making. As scientists learn more about C. botulinum spores and other potential hazards, manufacturers can use that knowledge to improve supplier management, testing procedures and preventive safety controls.
The work also reflects a larger trend in food manufacturing toward proactive food safety. Instead of waiting for problems to occur, companies are increasingly using research, supply chain monitoring, laboratory testing and risk assessment to identify potential issues earlier.
For families who depend on infant formula, these efforts are ultimately about ensuring that products remain safe, nutritious and reliable. The latest roadmap provides another step toward building stronger infant formula safety practices based on science, data and collaboration.
