# Understanding the INFANTS Act of 2025

This bill creates new safety requirements for baby food and infant formula manufacturers to test their products for harmful contaminants before they reach store shelves. The law focuses on protecting babies and toddlers up to 24 months old by requiring food companies to regularly check for toxic elements like lead, cadmium, mercury, and arsenic—substances that can cause serious health problems in young children.

Here's what the law requires: Any company that manufactures or processes baby food and infant formula must now create a written testing plan and collect samples of their products at least four times per year. These samples get tested for dangerous contaminants at accredited laboratories. The companies have to keep detailed records of all this testing for at least two years or for as long as the product stays on shelves, whichever is longer. If a company fails to do this testing, their product is considered unsafe and can be removed from the market. The FDA can also demand to see these testing records without having to physically inspect the facility, making oversight faster and easier.

For infant formula specifically, the law adds extra protections. Manufacturers must now test for harmful bacteria like Cronobacter and Salmonella in their facilities and report any positive test results to the FDA within 24 hours. They also have to set up environmental monitoring programs to make sure their manufacturing facilities stay clean and safe. If the FDA finds that a baby food product contains contaminants that make it unsafe, the agency now has the power to order a mandatory recall rather than just asking companies to voluntarily remove products from shelves.

The requirements don't kick in immediately—companies get 180 days after the FDA issues guidance to start complying, giving manufacturers time to set up their testing systems and plans.

INFANTS Act of 2025

Sykes, Emilia Strong

Improving Newborns’ Food and Nutrition Testing Safety Act of 2025 or the INFANTS Act of 2025This 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.