The INFANTS Act of 2025 (H.R. 2472) would substantially expand FDA/FD&C Act requirements to improve the safety of infant and toddler foods, including infant formula. Key elements include mandatory contaminant sampling and testing for infant and toddler foods, stricter recordkeeping and laboratory standards, new adulteration penalties for noncompliance, expanded recall authority for adulterated products (primarily non-infant-formula foods), and new environmental monitoring requirements aimed at Cronobacter and Salmonella in powdered infant formula. The bill also enhances rapid reporting of positive pathogen results in infant formula, and it authorizes the FDA to request records in lieu of inspections in certain circumstances. Several provisions include delayed applicability to give industry time to comply. The act defines “infant and toddler food” to cover foods intended for children up to 24 months (including infant formula). It also creates a new sampling/testing regime with quarterly testing, requires written sampling plans, and requires laboratories to be internationally accredited. In addition, it adds environmental monitoring for Cronobacter and Salmonella in powdered infant formula and sets timelines for notification, disposal, and FDA verification of corrective actions. Overall, the bill aims to tighten safety oversight, speed responses to hazards, and improve transparency in testing and compliance.
Key Points
- 1Establishes a new contaminant sampling and testing regime for infant and toddler foods, including infant formula, with written sampling plans, quarterly testing, and testing for lead, cadmium, mercury, arsenic, and other regulated contaminants; requires guidance within 18 months and delayed applicability of 180 days after guidance is published.
- 2Makes noncompliance with the new sampling/testing requirements an adulteration of the food under the FD&C Act, strengthening enforcement against noncompliant products.
- 3Grants expanded recall authority: the Secretary may order recalls for infant and toddler foods (other than infant formula) if a contaminant renders a product adulterated under the law.
- 4Adds a mandatory environmental monitoring requirement for powdered infant formula to verify sanitation and hygiene controls related to Cronobacter spp. and Salmonella, including written programs, sampling plans, recordkeeping, and access to records; compliance is delayed for 180 days after enactment.
- 5Requires rapid reporting and action for positive pathogen results in infant formula: manufacturers must notify the Secretary within 24 hours of confirmation of a positive environmental pathogen result, consult on proper disposal, provide results and isolates, and the FDA must verify corrective actions within 90 days.