- The Reagan-Udall Foundation recently released a report summarizing lessons learned following investigations into 2025 and 2026 infant formula recalls due to the presence of Clostridium botulinum (C. botulinum). The report follows a July 13, 2026, roundtable in which participants representing the infant formula industry, academia, consumer advocacy groups, and FDA discussed these recalls and provided recommendations to increase the understanding of risks and strengthen controls in the infant formula supply chain.
- The report focuses discussion in five key areas: (1) C. botulinum state of the science; (2) data sharing; (3) a collaborative, multifactorial approach to maintain infant formula safety; (4) FDA collaboration; and (5) potential next steps. The report outlines current challenges and includes recommendations in each of these areas to “advance research, establish standardized and fit-for-purpose testing methods, strengthen data sharing, validate preventive controls, and improve collaboration across industry, academia, and government.”
- According to the report, the recent infant formula recalls have quickly accelerated knowledge relating to testing for C. botulinum in infant formula powder, as well as safety throughout the supply chain. The report emphasized that industry-wide collaboration is essential to develop “solutions that are scientifically credible, operationally and economically feasible, regulatorily sound, and grounded in risk-based decision-making.”
- Keller and Heckman will continue to report on updates related to infant formula manufacturing and general food safety.
