Infant Formula Safety Modernization Act of 2026

Key Points

• The bill requires infant formula manufacturers to test both their factories and finished products for dangerous germs like botulism. The FDA must create and maintain a list of pathogens that all manufacturers must screen for.
• If a manufacturer finds a dangerous germ in finished formula, they must notify the government within one business day, even if the product has not been shipped to stores. This ensures early detection of contamination risks.
• The bill mandates environmental testing in specific zones of manufacturing facilities, including areas adjacent to where formula is made and areas further away but still in the processing environment.
• Congress must be notified within one business day whenever the FDA learns about a positive pathogen test in finished formula or issues an enforcement action after a factory inspection. This keeps lawmakers in the loop to respond quickly to potential shortages or safety crises.
• The new safety standards apply equally to all infant formula sold in the U.S., whether made domestically or imported. The FDA must enforce consistent inspection and compliance standards regardless of country of origin.