The U.S. Food and Drug Administration (FDA) is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level.
The FY 2025 request, which covers the period between October 1, 2024 and September 30, 2025, includes new efforts for high-priority program areas. Highlights of the agency’s request related to food safety and operational improvements include:
- $15 million to enhance food safety and nutrition: Funds for FDA’s human foods initiatives will modernize the agency’s capacity to prevent or mitigate foodborne illness outbreaks by investing in necessary tools and processes to strengthen root-cause investigations. The budget request also supports FDA in addressing the enormous public health burden of diet-related chronic diseases and the goals of the President’s National Strategy for Hunger, Nutrition, and Health.
- $12.3 million to address supply chain disruptions and support supply chain resiliency: Through an agency-wide crosscutting initiative, FDA will advance its capabilities to help prepare for, build resilience to, and respond to shortages through improved analytics and regulatory approaches. Among other initiatives, the agency will hire additional investigators to fulfill inspectional needs associated with increased supply-chain disruptions and consequent human food and medical product shortages in recent years.
- $114.8 million to support public health employee workforce: This funding will help FDA cover estimated inflationary pay costs and cost-of-living adjustments to minimize reductions to hiring capabilities and maintain the agency’s staff.
- $2 million increase to support agency modernization activities: Investments will be used by FDA to improve the efficiency of its operations by centralizing planning, implementation, and governance of high-priority business process improvement efforts. These include the continuation of the critical inspections platform implementation and expansion effort to implement common business processes and data optimization across the agency. The budget also proposes new two-year spending authority to support these investments.
- $8.3 million to modernize data infrastructure to best support agency operations. Funds will allow the agency to continue building FDA’s centralized enterprise data-modernization capabilities and strengthen its common data infrastructure. The budget also proposes new 2-year spending authority to support these critical investments.
- $1 million to expand foreign offices and strengthen imported products oversight: Funding will support the expansion of the agency’s foreign-office footprint, expanding agency resources to facilitate timely inspections of foreign facilities in specific countries. Additional deployed personnel would also improve oversight of imported products.
- $43.6 million to ensure optimal functioning of offices and labs: Funding will allow FDA personnel at facilities across the country to carry out its mission, including to evaluate food safety and medical products, continue to expand laboratory operations supporting inspections at points of entry to reduce the flow of adulterated and illicit imported products, and respond to emergencies. Optimally functioning facilities provide secure, modern, reliable, and cost-effective office and laboratory space that empowers FDA’s workforce to protect and promote food safety and public health.
To complement the funding requests, the agency’s budget proposal also includes a package of legislative proposals designed to better support agency efforts to protect American consumers and patients. Notable proposals include efforts to:
- Enhance supply-chain resiliency for drugs, medical devices, and foods, including with respect to addressing supply disruptions
- Provide new authorities to help ensure the safety of foods, including infant formula, medical foods, and foods marketed for infants and young children, which includes new authority to set binding contaminant limits by administrative order, requirements for contaminant testing of final products, more frequent environmental monitoring for pathogens in certain facilities, and mandatory reporting when certain products test positive for pathogens
- Support innovation and competition, such as creating a new regulatory category of animal food additives to facilitate marketing of innovative animal food products, as noted in the agency’s Animal and Veterinary Innovation Agenda
- Provide additional oversight tools, such as expanding authorities for information-sharing with states, broadening authority to request records or other information in advance of or in lieu of inspections to all FDA-regulated commodities, and requiring importers to destroy products that present a significant public health concern.
- Provide FDA with additional authorities to increase oversight of dietary supplements to better protect consumers from dangerous and otherwise illegal products on the market.