INFANTS Act Mandates Quarterly Heavy Metal Testing for All Baby Food, Grants FDA Mandatory Recall Power

The Improving Newborns’ Food and Nutrition Testing Safety Act of 2025, or the INFANTS Act, is exactly what it sounds like: a major tightening of the rules around what goes into the food we feed our youngest kids. This bill mandates comprehensive, quarterly testing for toxic elements in all food marketed for children up to 24 months old, including infant formula. It also hands the Secretary of Health and Human Services (HHS) mandatory recall authority and requires manufacturers to report positive pathogen tests within 24 hours.

The New Bottom Line: Quarterly Testing for Toxic Elements

If you run a facility making baby or toddler food, the game has changed. Under Section 3, you are now required to create a written sampling plan and test every product at least once every three months (quarterly) for four specific toxic elements: lead, cadmium, mercury, and arsenic. This isn't just a suggestion; it’s a hard rule. For parents, this is the biggest win in the bill. It targets the known issue of heavy metals showing up in baby food by forcing manufacturers to prove their product is clean before it hits the shelf.

Crucially, this testing must be done by an internationally accredited lab, and manufacturers must keep detailed records of the process for at least two years. If a company fails to follow these new testing and record-keeping requirements, Section 4 states that their food is automatically considered “adulterated” (unsafe) under federal law. This provision creates a direct, enforceable link between following the new safety procedures and legally selling the product.

Formula Factories Get a Double Check on Germs

Beyond heavy metals, the bill focuses heavily on preventing pathogen outbreaks in infant formula. Section 8 requires all powdered infant formula manufacturers to implement a mandatory, written environmental monitoring program. This means they must regularly test the manufacturing environment—not just the final product—for nasty bugs like Cronobacter spp. and Salmonella. They have to prove their cleaning procedures are actually working where contamination could happen.

If a formula manufacturer gets a positive test result for a relevant pathogen, Section 7 mandates they report it to the Secretary of HHS within a lightning-fast 24 hours of confirmation. After reporting, they have to work with the Secretary to safely dispose of the contaminated batch. This drastically cuts down the time between a company finding a problem and the government knowing about it, potentially preventing widespread shortages and illnesses like those seen in recent years.

When the Government Steps In: Mandatory Recalls and Record Access

Two provisions give the FDA and HHS much sharper teeth. First, Section 6 grants the Secretary mandatory recall authority over any infant or toddler food found to be adulterated with a contaminant. This means if the food is tainted, the government must step in and order the recall, removing any discretion or delay that might happen if the agency had to wait for the manufacturer to act.

Second, Section 5 clarifies and expands the FDA's ability to demand records before or instead of a physical inspection. For busy, well-regulated facilities, this might streamline the process. However, it also means the FDA can now request documentation—electronically or physically—at the company’s expense and within a reasonable timeframe, without the typical on-site inspection rules applying. For smaller facilities, this could translate into a significant administrative burden, as they must comply with potentially voluminous requests for records like sampling plans and test results.