Infant Formula Safety Modernization Act of 2026

Infant Formula Safety Modernization Act of 2026

This bill directs the Food and Drug Administration (FDA) to expand requirements for the testing of infant formula and formula manufacturing facilities for pathogens and microorganisms.

Current regulations generally require manufacturers to test finished formula products for Cronobacter and Salmonella. The FDA tests manufacturing facilities for these contaminants in regular inspections, but manufacturers are not required to test their own facilities.

Within 90 days of the bill's enactment, the FDA must issue a final rule requiring manufacturers to test their facilities and finished formula products for certain pathogens and microorganisms, including Clostridium botulinum (which causes botulism). These regulations must include a recommended frequency for facilities testing, including requirements for testing different areas based on their proximity to formula products.

Manufacturers must notify the FDA within one business day of any positive result for one of the specified pathogens or microorganisms in a finished formula product, even if the product is still in the manufacturer’s possession. (Currently, notice is required only if the affected product has left the manufacturer’s facilities.) Manufacturers must also retain records of any positive result (from a test of formula or facilities).

The FDA must notify Congress within one business day of

• receiving notice of a positive test result for a finished formula product, or
• recommending official corrective action to address the findings of a facility inspection.

Finally, the regulations must explicitly require the FDA to enforce consistent inspection and compliance standards for all formula products, including imported products.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov