Reagan‑Udall Roundtable Issues Practical Recommendations to Address C. botulinum in Powdered Infant Formula

What changed: the outbreak link to dairy ingredients Investigations connected both outbreaks to a shared organic powdered whole milk ingredient supplied by Organic West Milk (OWM) and processed by Dairy Farmers of America (DFA). Whole genome sequencing (WGS) matched the outbreak strain across clinical isolates and ingredient/finished‑product samples. FDA concluded that the OWM/DFA powdered milk ingredient was the common contamination source, though it has not determined whether contamination occurred before or during milk drying.

Participants pinpointed several knowledge and capability gaps that limit targeted risk reduction:

• Prevalence data: There is inadequate surveillance across farms, ingredient supply chains, and finished products to know where spores originate or accumulate.
• Testing limitations: No standardized industry method exists for detecting C. botulinum or spores in powdered formula. Some testing approaches, including standard SRC testing, can miss trace spore levels that may still pose infant risk. Few laboratories can run these assays because of organism and toxin biosecurity requirements.
• Preventive controls: Industry lacks validated, agreed‑upon preventive controls specific to dairy collection, milk drying, and downstream formula manufacturing for controlling spore contamination.
• Data sharing and coordination: Limited sharing of supply‑chain and testing data reduces the ability to detect common sources and align responses.

• Conduct prevalence research at farm, ingredient, processing, and finished‑product levels to map where spores are introduced or concentrated and how environmental, regional, or climate conditions affect prevalence.
• Prioritize development and validation of more sensitive and standardized detection methods for C. botulinum and spores, and expand laboratory capacity to run them under appropriate biosafety conditions.
• Validate preventive controls targeted to dairy production and ingredient processing steps, including interventions that could reduce spore loads before milk drying and during processing.
• Improve industry data‑sharing mechanisms for testing results and supply‑chain information to speed source identification and coordinated action across suppliers and manufacturers.
• Request FDA guidance that defines fit‑for‑purpose testing approaches and thresholds for C. botulinum in powdered infant formula and ingredients.

Implications for industry and regulators The roundtable frames C. botulinum as an emergent powdered formula hazard that requires coordinated research and harmonized practice. For manufacturers and ingredient suppliers, the report recommends prioritizing surveillance and preventive measures across the dairy supply chain and engaging in shared testing and incident data. For regulators, the report seeks clearer guidance on acceptable testing methods and thresholds so industry can align controls with regulatory expectations. Next practical steps for stakeholders Stakeholders can begin by supporting or funding targeted prevalence studies, convening validation studies for new assays, reviewing farm‑to‑dryer controls for spore reduction, and establishing confidential data‑sharing channels among suppliers, manufacturers, and regulators to accelerate root‑cause detection and outbreak prevention.