FDA Policy Tracker: 2025 Was a Year of Change
FDA delayed FSMA 204 Traceability Rule compliance from January 2026 to July 2028 on March 20, 20251.
HHS announced plans in March 2025 to eliminate self-affirmed GRAS pathway, with proposed rulemaking slated for October 20253.
FDA published over 200 Complete Response Letters (CRLs) for drug and biologics applications from 2020-2024 on July 10, 2025, enhancing transparency2.
FDA issued 58 novel drug approvals in 2025 despite agency upheaval, with 46 from CDER and 12 from CBER7.
MAHA Commission report on September 9, 2025, outlined goals like phasing out synthetic food dyes and reforming infant formula oversight13.
FDA encouraged baby food and infant formula manufacturers to improve recall awareness and outlined short- and long-term goals for recall processes on July 9, 20252.
Significant FDA staff reductions and restructuring rumors, including potential consolidation of review divisions, impacted policy and surveillance like FoodNet cuts18.
Sources:
1. https://www.food-safety.com/articles/11004-a-2025-timeline-of-us-federal-food-safety-changes-under-the-trump-admin
2. https://www.hklaw.com/en/insights/publications/2025/07/recent-fda-actions-pose-big-changes-and-questions-for-health
3. https://www.mintz.com/insights-center/viewpoints/2791/2025-10-16-fda-flux-october-2025-newsletter
7. https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/us-fda-holds-steady-with-58-novel-approvals-in-2025-despite-upheaval-NWHBCZPCXFDQ3JZMK6GFYKRV4Y/
8. https://www.iqvia.com/locations/united-states/blogs/2025/04/a-new-fda-preparing-uncertain-landscape