This bill changes how infant formula contamination and supply are handled. It amends the part of federal statute that covers infant formula safety and testing. Key changes: manufacturers must notify officials faster when they learn of possible contamination; specifically, notifications must be made within 1 business day of acquiring knowledge. If a finished product test is confirmed positive for a microorganism covered by current FDA testing rules (21 CFR 106.55(e)), the manufacturer must: notify the Secretary within 1 business day, work with the Secretary to isolate affected product, and, if the Secretary requires, stop distribution and dispose of the affected product. The manufacturer must also give the Secretary test results and isolates or the whole genetic sequence from the positive sample.
The Secretary must respond to a manufacturer within 1 business day after a positive notification to begin investigation and corrective action discussions. The Secretary must confirm within 90 days that the manufacturer performed or is performing an appropriate investigation and corrective actions. The Secretary must consider the lab methods used and the potential for cross-contamination and may review documentation electronically and by inspection.
The bill also adds reporting requirements. The Secretary must issue a progress report within 180 days on implementing recommendations from the FDA's January 2025 "Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market." Starting 270 days after enactment and for five years, the Secretary must send quarterly reports on critical infant formula supply chain data (including in-stock rates) to specified congressional committees. The Secretary must consult with the Department of Agriculture and other agencies. At 1, 3, and 5 years after enactment, the Secretary must engage stakeholders to identify evidence-based practices (for example, the value of high-frequency testing and effects of corrective actions) and report recommended changes to manufacturer practices to the same committees.
No publicly available information on costs, funding, or new appropriations is included in the bill text.
The bill focuses on improving infant formula safety and supply resilience by requiring faster notifications of contamination, clearer testing and sample sharing from manufacturers, quicker federal response and review, and regular reporting on supply chain data and recommended manufacturer practices.
No publicly available information on opposition or critiques is included in the bill text or metadata.