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 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) is amended—
(1) by redesignating subparagraphs (B), (C), and (D) as subparagraphs (C), (D), and (E), respectively;
(2) by inserting after subparagraph (A) the following:
(B)
(i) Any records or other information that the Secretary may inspect under authority of this Act from a person that owns or operates an establishment that is engaged in any of the activities described in clause (ii) shall, upon the request of the Secretary, be provided to the Secretary by such person, 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 person. The Secretary’s request shall include a sufficient description of the records requested.
(ii) The activities described in this clause are the following:
(I) The manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing of an article of food.
(II) The distribution or use of animal feed bearing or containing a veterinary feed directive drug, or the issuance of a veterinary feed directive.
; and
(3) by adding at the end the following:
(F) Section 703 does not apply to requests for records or other information when those requests are made under this section.