H.R. 2472
INFANTS Act of 2025
Official summary
Written by the Congressional Research Service.
Improving Newborns’ Food and Nutrition Testing Safety Act of 2025 or the INFANTS Act of 2025
This bill requires infant and toddler food to be tested periodically for contaminants and imposes other safety requirements on food and formula manufacturers.
Specifically, the bill requires facilities that manufacture or process infant and toddler food in final form to conduct quarterly tests for contaminants, including lead and arsenic. The Food and Drug Administration (FDA) may subject other foods to this requirement as appropriate. If a facility that is subject to these requirements fails to comply, food manufactured or processed there is deemed adulterated and may not be introduced into interstate commerce.
The bill also specifies that if the FDA determines an infant and toddler food, other than infant formula, contains a contaminant that renders the food adulterated, the FDA must provide the responsible party with an opportunity to initiate a voluntary recall. (Under current law, if a responsible party does not voluntarily recall an adulterated product, the FDA may impose a mandatory recall.)
Further, if testing of an infant formula reveals the presence of certain pathogens, including Listeria monocytogenes or Salmonella, the manufacturer must (1) notify the FDA within 24 hours, (2) properly dispose of the product, and (3) provide the FDA with test results and isolates from the formula.
Finally, the bill requires manufacturers of powdered infant formula to monitor the effectiveness of sanitation and hygiene controls where the formula has the potential to be exposed to Cronobacter spp. or Salmonella.
Text of the bill
Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the following:
(n) Requirements for environmental monitoring for Cronobacter spp and Salmonella
(1) In general. A manufacturer of powdered infant formula shall establish and implement an environmental monitoring program to verify the effectiveness of sanitation and hygiene controls where the food has the potential to be exposed to Cronobacter spp. or Salmonella. The environmental monitoring program shall be written and include procedures for determining sampling location, number of samples to be taken, and timing and frequency of sample collection and testing.
(2) Sampling location and number of samples. A manufacturer of powdered infant formula shall ensure that the sampling locations from which samples will be taken, and the number of sites to be tested during routine environmental monitoring pursuant to an environmental monitoring program under paragraph (1), are adequate to determine whether sanitation and hygiene controls are effective.
(3) Timing and frequency. A manufacturer of powdered infant formula shall ensure that the timing and frequency for collecting testing samples pursuant to an environmental monitoring program under paragraph (1) are adequate to determine whether sanitation and hygiene controls are effective.
(4) Records
(A) Availability to the Secretary. A manufacturer of powdered infant formula shall make all records required under this subsection available promptly to the Secretary, upon request, for inspection and copying.
(B) Maintenance. Records of environmental monitoring conducted pursuant to this subsection shall be maintained for not less than 2 years or the shelf-life of the infant formula, whichever is longer.
(C) Conditions of inspection. Any records that the Secretary may inspect under this subsection shall, upon the request of the Secretary, be provided to the Secretary by the manufacturer of powdered infant formula, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such manufacturer. The Secretary’s request shall include a sufficient description of the records requested.
(D) Confirmation of receipt. Upon receipt of records requested under subparagraph (C), the Secretary shall provide to the person confirmation of receipt.
(5) Authority of the Secretary. Nothing in this subsection supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.
(6) Delayed applicability. The requirements of this subsection apply beginning on the date that is 180 days after the date of enactment of this subsection.
(7) Rule of construction. Nothing in this subsection shall be construed to exempt an infant formula manufacturer from the requirements of this Act, including the requirements of this section and section 418.