Protect Infant Formula from Contamination Act
Summary
What This Bill Does
The Protect Infant Formula from Contamination Act amends the Federal Food, Drug, and Cosmetic Act to tighten notification and reporting rules for infant formula safety. If finished infant formula product testing confirms a positive result for a microorganism that must be tested under FDA rules, the manufacturer must notify FDA within one business day and provide related information about the contaminated production aggregate.
The bill also requires FDA to report on implementation of its January 2025 long-term national strategy for infant formula market resiliency. FDA must issue a progress report within 180 days and then provide quarterly supply-chain reports on domestic production, imports, recalls, shortages, and other market-resiliency information.
Who Benefits and How
Infants, parents, caregivers, families dependent on infant formula, pediatric clinicians, Congress, and infant-formula safety watchdogs benefit from faster contamination notification and more frequent supply-chain reporting. Earlier FDA notice can speed investigation of contaminated formula, and quarterly reports give Congress and the public better visibility into safety and shortage risks.
Who Bears the Burden and How
Infant formula manufacturers must notify FDA within one business day after confirmed positive microorganism test results and provide production-aggregate information. FDA must process contamination notices, issue a 180-day implementation report, and prepare recurring quarterly supply-chain reports. Formula companies may also face more scrutiny when recalls, shortages, imports, or contamination events affect supply.
Key Provisions
- Requires infant formula manufacturers to notify FDA within one business day after confirmed positive microorganism test results.
- Requires notices to identify affected production aggregates and related information.
- Requires FDA to report on implementation of its January 2025 infant-formula resiliency strategy.
- Requires quarterly reports on infant formula supply-chain conditions.
- Requires reporting on domestic production, imports, recalls, shortages, and safety issues.
- Gives Congress more regular oversight information on infant formula safety and supply.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Tightens FDA notification and congressional reporting requirements for infant formula contamination, safety, and supply-chain resiliency.
Key Policy Areas
Healthcare, Food Safety, Consumer Protection
Primary Purpose
Tightens FDA notification and congressional reporting requirements for infant formula contamination, safety, and supply-chain resiliency.
Policy Domains
Whole bill
Identified Gains
- Infants
- Parents
- Caregivers
- Families dependent on infant formula
- Pediatric clinicians
- Congress
- Infant-formula safety watchdogs
Identified Costs
- Infant formula manufacturers
- Food and Drug Administration
- Formula testing laboratories
- Formula companies facing recalls
Sponsors
Legislative Progress
Passed SenateHeld at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed/agreed to in Senate: Passed Senate with an amendment and …
Passed Senate with an amendment and an amendment to the …
Placed on Senate Legislative Calendar under General Orders. Calendar No. …
Reported by Mr. Cassidy, with an amendment and an amendment …
Committee on Health, Education, Labor, and Pensions. Reported by Senator …
Committee on Health, Education, Labor, and Pensions. Ordered to be …
Mr. Peters (for himself and Mr. Hoeven) introduced the following …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Congress, Food and Drug Administration
Positive-direction: Congress
Negative-direction: Food and Drug Administration
Families dependent on infant formula, Parents using infant formula
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "secretary"
- → Secretary of Health and Human Services or FDA
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology