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.