Protect Infant Formula from Contamination Act
The Protect Infant Formula from Contamination Act would tighten and speed up how infant formula contamination is detected, reported, and acted upon. The bill requires manufacturers to promptly notify the FDA (within 1 business day) when a finished infant formula product from any production batch tests positive for a microorganism, and to work quickly with the FDA to isolate and, if needed, stop distribution of affected product and dispose of it. It also requires the FDA to respond quickly to these notifications and, within 90 days, verify that the manufacturer conducted an appropriate root-cause investigation and corrective actions, with documentation that the FDA can review. In addition, the bill creates new reporting requirements to monitor and improve the safety and supply of infant formula over time, including regular supply-chain data reports and ongoing interagency coordination. Overall, the measure aims to prevent contaminated formula from reaching babies and to build resilience in the formula supply chain. Note: The bill’s title mentions toxic elements, but the text of the bill focuses on testing for microorganisms and related actions; no specific provisions about toxic elements are described in the sections provided.
Key Points
- 1Mandatory rapid notification: When a finished infant formula sample from any production batch tests positive for a microorganism, manufacturers must notify the Secretary (FDA) within 1 business day of acquiring the confirmed result, and this applies even if the product hasn’t left the manufacturing facility.
- 2Immediate actions for manufacturers: Upon a positive result, manufacturers must promptly consult with the FDA on proper isolation, may need to cease distribution and dispose of affected product as directed, and must provide the FDA with test results, isolates, or the genetic sequence of the positive result.
- 3FDA response and oversight: The FDA must respond within 1 business day after notification to begin discussions on investigation and corrective action, and share findings as appropriate.
- 4Verification and documentation: Within 90 days of notification, the FDA must confirm that the manufacturer conducted an appropriate investigation and corrective actions, considering root-cause analysis and potential cross-contamination; manufacturers must provide documentation electronically and be available for inspection.
- 5New reporting and oversight on safety and supply: The bill adds new reporting requirements (progress reports within 180 days, quarterly supply-chain reports for 5 years, and periodic reviews at 1, 3, and 5 years) and directs ongoing interagency consultation to improve both safety and the supply of infant formula, including potential adoption of high-frequency testing and other best practices.