IDFA Supports New Report Charting Path Forward on Infant Formula Safety

The International Dairy Foods Association (IDFA) today welcomed the release of a new report from the Reagan-Udall Foundation for the FDA (Foundation) outlining a science-based roadmap for industry, government and academic partners to address Clostridium botulinum (C. botulinum) risk in powdered infant formula. Central to that roadmap is the need to better understand the prevalence of C. botulinum spores across the infant formula supply chain so that interventions can be targeted where they will be most effective.

The report, Applying the Science of Infant Formula Safety: Insights From Recent Recall Activity and the Latest Research on C. botulinum, follows a July 13 roundtable convened by the Foundation with representatives from the infant formula industry, the U.S. Food and Drug Administration (FDA), academia and a consumer advocacy organization. IDFA was among several sponsors of the roundtable, assisted with the preparation of the report, and will support continuing efforts to engage with stakeholders in the dairy supply chain to implement the established roadmap.

The roundtable was organized in response to an emerging food-safety challenge. Prior to recent infant botulism events, C. botulinumspores were not considered a contamination risk of concern in infant formula based on existing scientific risk assessments and international guidance. Recent events have challenged that understanding and raised new questions about the prevalence of C. botulinumspores, how and where they may enter the infant formula production supply chain, what type of interventions are effective at mitigating spore loads, and what are appropriate testing methods needed to identify and verify that the risk is managed effectively.

“The safety of the products and ingredients our industry produces is our chief responsibility,” said Michael Dykes, D.V.M., president and CEO of IDFA. “That responsibility requires us to respond when new emerging risks are identified. This report is the beginning of that response and work. It provides a roadmap for industry, regulators, and researchers to build the scientific foundation and evidence needed to ensure the right controls and practices are in place. Our industry is committed to doing that work and continually strengthening the safety of dairy products and ingredients for infants and their families.”

Roundtable participants agreed that a clear understanding of the prevalence of C. botulinum spores across the infant formula supply chain is the first data gap that needs to be addressed. Currently, we lack a complete understanding of where and to what levels spores may be introduced or concentrated across the supply chain from agricultural production through ingredient processing and finished powdered infant formula manufacturing. IDFA will continue to participate in the Cornell Pathogenic Spore Consortium that includes infant formula manufacturers, dairy ingredient suppliers, and researchers and do our part to facilitate the generation of prevalence data needed to close knowledge gaps. Establishing prevalence baselines are an essential first step toward gaining a better understanding of this risk and determining where the deployment of controls and mitigation strategies will have the greatest impact.

While this roundtable focused on infant formula manufacturers, the report calls for engaging with ingredient suppliers and other stakeholders across the broader supply chain to better understand where C. botulinum spores may be introduced or concentrated and to develop scientifically sound approaches for reducing risk throughout the supply chain.

“Infant formula safety is a shared responsibility and our industry is committed to doing its part,” Dykes said. “The right response to an emerging safety risk is collaboration, rigorous research and evidence-based action. This report brings together the best expertise across the infant formula industry, government and academia, and gives us a strong foundation for the next phase of work. We are committed to moving that work forward and taking appropriate action as the science and evidence warrant.”