INFANTS Act of 2025
Sponsored By: Representative Sykes, Emilia Strong [D-OH-13]
Introduced
Summary
Stronger testing and monitoring for infant and toddler foods. This bill would add mandatory sampling, contaminant testing, recordkeeping, and environmental monitoring for foods marketed for children up to 24 months, including infant formula.
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- Families and caregivers: Requires testing for lead, cadmium, mercury, arsenic, and other contaminants, and requires manufacturers to notify the agency within 24 hours of a positive pathogen result in infant formula.
- Manufacturers and facilities: Would require facilities to collect representative samples, test at least quarterly, keep a written sampling plan, and retain records for at least 2 years or the product's shelf-life, whichever is longer. Testing must be done by laboratories accredited to international standards.
- Regulators and recalls: Expands mandatory recall authority to cover contaminated infant and toddler foods other than infant formula, authorizes records requests in lieu of inspections for many activities, and directs the Secretary to issue guidance within 18 months with most requirements becoming applicable 180 days after that guidance is published.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 1 benefits, 0 costs, 3 mixed.
Environmental checks in powdered formula
Powdered infant formula makers would have to run an environmental monitoring program for Cronobacter and Salmonella. They would set where to sample, how many samples to take, and how often to test to verify sanitation and hygiene controls. Records would be kept for 2 years or the formula’s shelf-life and shared with the FDA on request, including in advance or instead of an inspection. These rules would start 180 days after enactment.
24-hour reporting on tainted formula
If a manufacturer finds a positive test for a pathogen in in-process or finished infant formula, they would have to notify the FDA within 24 hours. They would consult on disposal, dispose of affected product, and share test results and isolates. The FDA would confirm within 90 days that corrective actions are underway or done, with documentation available during inspections.
Regular contaminant testing for baby foods
Food facilities that make or process infant and toddler foods would need to test products at least every quarter. Tests would check for lead, cadmium, mercury, arsenic, and any other contaminants the FDA names. Labs would need international accreditation, and facilities would keep records for 2 years or the product’s shelf-life. The FDA would publish guidance within 18 months, and these testing rules would start 180 days after that guidance. If a facility fails to follow these rules, the food could be treated as adulterated. The bill defines infant and toddler food as products for children up to 24 months old, including infant formula.
Stronger FDA recalls and records access
The FDA would be able to order recalls of infant and toddler foods (not infant formula) that are contaminated and adulterated. The FDA could also require food businesses to send records in advance of or instead of an inspection, within a reasonable time and in electronic or paper form. Businesses would bear the costs of providing records, and the FDA must clearly describe what it wants.
Sponsors & CoSponsors
Sponsor
Sykes, Emilia Strong [D-OH-13]
OH • D
Cosponsors
Pallone
NJ • D
Sponsored 3/27/2025
Rep. Krishnamoorthi, Raja [D-IL-8]
IL • D
Sponsored 3/27/2025
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 4/7/2025
Rep. Magaziner, Seth [D-RI-2]
RI • D
Sponsored 4/27/2026
Rep. Lawler, Michael [R-NY-17]
NY • R
Sponsored 4/29/2026
Roll Call Votes
No roll call votes available for this bill.
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