Congress Targets Faster FDA Alerts and Follow-Up When Infant Formula Tests Positive for Contamination

FDA starts enforcing 1-business-day notification and response timelines after confirmed positive formula tests

If a required germ test comes back confirmed positive, companies must alert FDA fast and FDA must respond fast, which can speed up holds and recalls

FDA confirms within 90 days that a manufacturer investigated and fixed the cause after a contamination notification

Companies can’t just report a problem; FDA is expected to check the follow-through, which can improve long-term safety practices

FDA issues a progress report on its January 2025 national strategy for formula safety and supply

Families and lawmakers get an update on what actions are actually happening to prevent contamination and reduce shortages

FDA begins quarterly supply chain reports to Congress (including in-stock rates)

Shortages may be spotted and escalated faster because the government is required to track and share key supply signals regularly

FDA publishes an “adequacy of supply” report after gathering input from the public and manufacturers

This can result in recommended best practices that aim to keep formula both safe and available, but recommendations may not be mandatory

FDA publishes follow-up “adequacy of supply” reports

Keeps pressure on ongoing improvements and can show whether supply and safety steps are working over time