S. 272 — Protect Infant Formula from Contamination Act

This section revises notification requirements under the Federal Food, Drug, and Cosmetic Act for infant formula manufacturers regarding testing results by (1) requiring notification to the Secretary within 1 business day of acquiring knowledge of certain issues (from "promptly"); (2) requiring, for confirmed positive tests for microorganisms subject to finished product testing under 21 CFR 106.55(e) (i.e., Salmonella, Cronobacter, and Listeria monocytogenes), notification within 1 business day regardless of whether product has left the manufacturer's control, prompt consultation on isolation/cessation/disposal of affected product as required, and provision of results, isolates, or whole genome sequence data; (3) requiring the Secretary to respond within 1 business day of such notifications to discuss investigation and corrective action and share findings as appropriate; and (4) requiring the Secretary, within 90 days of any notification, to confirm—through documentation review including analytical methods and cross-contamination risks—that the manufacturer performed an appropriate investigation and corrective action, with records available electronically and for inspection.

This section requires the Secretary of Health and Human Services (FDA) to submit multiple reports on improving infant formula safety and supply, as added to Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a). Specifically, it directs: (1) a progress report within 180 days of enactment on implementing recommendations from FDA's January 2025 report, "Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market," including any needed additional authorities or resources and revisions due to post-publication recalls; (2) supply chain reports with critical data (e.g., in-stock rates) beginning 270 days after enactment and quarterly thereafter for five years to specified Senate and House committees (i.e., Health, Education, Labor, and Pensions; Agriculture, Nutrition, and Forestry; Energy and Commerce; Agriculture; and Appropriations Agriculture, Rural Development, FDA, and Related Agencies Subcommittees); (3) consultation with USDA and other agencies on immediate needs and long-term market resiliency; and (4) reports at one, three, and five years after enactment, following stakeholder engagement, identifying evidence-based manufacturer practice modifications (e.g., high-frequency testing for contaminants like botulism, bracketing potentially contaminated product, and corrective actions) to enhance supply and safety.