The Food and Drug Administration
Summary
FDA runs on a $7.0 billion FY2026 enacted total program level and 18,057 federal FTEs -- and just over half of that money, $3.64 billion, comes not from taxpayers but from user fees the drug, device, and tobacco industries FDA regulates are required to pay.
What is this organization?
What does it do?
In FY2025, FDA completed more than 14,600 domestic inspections, more than 2,600 foreign inspections, and more than 159,600 import examinations⧉ -- the front line of its food, drug, device, and tobacco oversight. Its Office of Criminal Investigations that year opened cases resulting in 117 arrests, 129 convictions, and more than $340 million in forfeiture, fines, and restitution⧉.
What does it cost to run — money and people?
Congress enacted $3,353.892 million in FY2026 budget authority⧉ for -- taxpayer-funded -- plus $3,641.328 million in industry-paid user fees⧉ under PDUFA, MDUFA, and related statutes, for a total FY2026 enacted program level of $6,995.220 million and 18,057 FTEs (9,465 appropriated, 8,592 fee-funded; FDA's own FY2026 FTE figures are October-1-2025 estimates⧉). Against the Census Bureau's 341.8 million U.S. residents⧉ as of July 2025, that's about $20.47 per person.
View data as table
| Budget authority (appropriated) | 3,353.9 | taxpayer-funded, 9,465 FTE |
|---|---|---|
| User fees (industry-paid) | 3,641.3 | PDUFA/MDUFA/GDUFA/BsUFA/ADUFA/tobacco fees, 8,592 FTE |
Why is it good for society?
The FD&C Act's core mechanism is premarket proof of safety: it required a manufacturer to prove to FDA a drug was safe before selling it. The counterfactual is the disaster that forced the law through Congress: in 1937, an untested solvent in Elixir Sulfanilamide killed over 100 people, many of them children, because no law required proof of safety first. Every inspection today extends that same check.
- 's FY2026 enacted total program level ($6,995.220 million, 18,057 FTEs) works out to about $20.47 per U.S. resident -- but only about 48% of that ($3,353.892 million) is taxpayer-funded budget authority; the rest is user fees the regulated industries themselves pay.
- The Act that created 's premarket safety-review authority was written in direct response to a documented body count: over 100 deaths, many of them children, from an untested drug solvent in 1937 -- before federal law required any proof of safety before a drug could be sold.
Your handles.* Suspect a bad drug, device, or vaccine reaction? File it on FDA's MedWatch form⧉. Found a problem with food or another product? Use Report a Problem to FDA⧉. Want to issue, amend, or comment on a rule? See FDA's petition and docket-comment process⧉ under 21 CFR 10.30.
Sources(7) ▾
- U.S. Department of Health and Human Services, Food and Drug Administration, Food and Drug Administration, Fiscal Year 2027 Justification of Estimates for Appropriations Committees (2026-03-01) — 's own FY2027 congressional budget justification. The 2027 All Purpose Table (pp.7-9) gives the FY2025 Final / FY2026 Enacted / FY2027 President's Budget summary of 's budget authority, user fees, total program level, and staffing this entry's KPIs and chart come from -- the totals row this entry uses is the table's NCTR-excluded 'displayed comparably' figures (see f-fda-fy26-programlevel for the including-NCTR alternative). Also the source for 's statutory mission statement (Executive Summary, Introduction and Mission) and the Office of the Commissioner's FY2025 inspection, import-examination, and criminal-enforcement workload figures (p.65-66). fda.gov · original document
- U.S. Food and Drug Administration (Office of the Commissioner), Part II: 1938, Food, Drug, Cosmetic Act (2018-11-27) — 's own official history of the 1938 Food, Drug, and Cosmetic Act -- the signing date, the premarket-safety-proof requirement the Act created, and the Elixir Sulfanilamide disaster (over 100 deaths) that forced its passage. A single archive.org Save Page Now request was attempted for this URL and returned HTTP 520 (site-wide capture outage); no earlier snapshot exists in the Wayback index either, so capture is recorded null per this run's non-blocking Wayback-outage rule. Content verified live via direct HTTP fetch instead. fda.gov
- U.S. Food and Drug Administration (Office of the Commissioner), FDA's Origin (2018-01-31) — 's own account of its 1906 origin as the Bureau of Chemistry, its July 1930 renaming to the Food and Drug Administration, and its 1980 move into the newly created Department of Health and Human Services. Same Wayback-outage note as doc-fda-1938-act applies; capture is null, content verified live. fda.gov
- U.S. Census Bureau, U.S. Population Growth Slows Due to Historic Decline in Net International Migration (Vintage 2025 national population estimate) (2026-01-27) — The source for the July 1, 2025 U.S. resident population estimate (341.8 million) used as the per-resident KPI's denominator. Same document the good-citizen-cms, good-citizen-hhs-oig, and good-citizen-dod-oig entries already rely on. census.gov · original document
- U.S. Food and Drug Administration, MedWatch Online Voluntary Reporting Form (2026-07-16) — 's live MedWatch reporting portal -- the handle for reporting a suspected adverse reaction or product problem with a drug, device, or vaccine. Verified reachable (200) at access time. accessdata.fda.gov · original document
- U.S. Food and Drug Administration, Report a Problem to FDA (2026-07-16) — 's hub page routing consumers to the correct complaint channel for a food, drug, device, cosmetic, or tobacco problem. Verified reachable (200) at access time. fda.gov · original document
- U.S. Food and Drug Administration, Dockets Management Staff, Comment on Proposed Regulations and Submit Petitions (2026-07-16) — 's own page explaining how the public can comment on a proposed regulation, in the Federal Register docket, or file a citizen petition under 21 CFR 10.30 asking to issue, amend, or revoke a rule. Verified reachable (200) at access time. fda.gov · original document
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is the HHS agency⧉ responsible for the safety, effectiveness, and security of drugs, biologics, and medical devices, food, cosmetics, and radiation-emitting products, and for regulating tobacco. Its lineage runs from the 1906 Federal Food and Drugs Act's Bureau of Chemistry, renamed the Food and Drug Administration in July 1930; its premarket-safety authority rests on the Federal Food, Drug, and Cosmetic Act, signed June 25, 1938. has been part of since 1980, headquartered on its White Oak campus in Silver Spring, Maryland.