The "Protect Infant Formula from Contamination Act" aims to significantly enhance the safety and reliability of the infant formula supply in the United States by strengthening regulatory oversight and reporting. It amends the Federal Food, Drug, and Cosmetic Act to impose stricter requirements on manufacturers regarding contamination events. Manufacturers must now notify the Secretary of a confirmed positive analytical result for any required microorganism testing in finished infant formula within one business day , even if the product has not left their control. They are also required to promptly consult with the Secretary for product isolation, cease distribution, and dispose of affected products as directed, while providing test results and genetic sequences from positive samples. The Secretary must respond within one business day to discuss investigations and confirm appropriate corrective actions within 90 days. To improve the infant formula supply chain, the bill mandates that the Secretary issue a progress report on implementing the FDA's long-term strategy for market resiliency and provide quarterly reports to Congress on critical supply chain data for five years. Additionally, the Secretary is required to engage with stakeholders and report to Congress at one, three, and five-year intervals on evidence-based practices to maximize infant formula supply and safety.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 306.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 306.
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Protect Infant Formula from Contamination Act
USA119th CongressS-272| Senate
| Updated: 1/28/2026
The "Protect Infant Formula from Contamination Act" aims to significantly enhance the safety and reliability of the infant formula supply in the United States by strengthening regulatory oversight and reporting. It amends the Federal Food, Drug, and Cosmetic Act to impose stricter requirements on manufacturers regarding contamination events. Manufacturers must now notify the Secretary of a confirmed positive analytical result for any required microorganism testing in finished infant formula within one business day , even if the product has not left their control. They are also required to promptly consult with the Secretary for product isolation, cease distribution, and dispose of affected products as directed, while providing test results and genetic sequences from positive samples. The Secretary must respond within one business day to discuss investigations and confirm appropriate corrective actions within 90 days. To improve the infant formula supply chain, the bill mandates that the Secretary issue a progress report on implementing the FDA's long-term strategy for market resiliency and provide quarterly reports to Congress on critical supply chain data for five years. Additionally, the Secretary is required to engage with stakeholders and report to Congress at one, three, and five-year intervals on evidence-based practices to maximize infant formula supply and safety.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 306.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 306.