Reagan-Udall Foundation Publishes Report on the Science of Infant Formula Safety

First Published Date: September 3, 2026

On July 13, 2026, the Reagan-Udall Foundation for the FDA, in collaboration with ByHeart and the International Dairy Foods Association (IDFA), convened an invitation-only roundtable to examine insights from recent infant formula recall activity and the latest research on Clostridium botulinum. Participants represented the infant formula industry, academia, consumer advocacy, and the FDA.

The resulting report, Applying the Science of Infant Formula Safety: Insights From Recent Recall Activity and the Latest Research on C. botulinum, summarizes lessons learned from manufacturer and regulatory investigations and is organized around five key areas: the state of the science, data sharing, a collaborative multifactorial approach to safety, FDA collaboration, and potential next steps. It presents recommendations to advance research, establish standardize testing methods, strengthen data sharing, and improve collaboration across industry, academia, and government. 

ByHeart shared its investigation findings, sample data, and evolved testing protocols to help establish a common scientific baseline for the discussion — work we're glad to have helped advance and remain committed to continuing.

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