FDA Shutdown

Bottom line up front: FDA will keep working on carryover user-fee–funded activities and life-safety work, but it cannot accept new user-fee submissions during the shutdown. Import screening at the border continues, though expect delays. Many USDA APHIS Veterinary Services (VS) functions tied to user fees (including animal import/export services) continue; other routine activities pause. Meat/poultry/egg inspections (USDA FSIS) continue as essential. (HHS.gov)

What’s actually shut down?

At 12:01 a.m. ET today (Oct. 1, 2025), the federal government entered a shutdown after Congress failed to pass FY 2026 funding. Expect agency-by-agency slowdowns and selective furloughs until funding is restored. (The Washington Post)

FDA: What continues—and what stops

Continues (exempt/excepted):

• Work funded by carryover user fees (e.g., certain reviews and marketing authorizations for drugs, biologics, devices; tobacco regulation).
• Life-safety functions: outbreak response, recalls, drug shortage mitigation, adverse event surveillance, review of import entries to identify health risks, and for-cause and certain surveillance inspections.
• FDA reports retaining ~86% of staff as exempt/excepted during a lapse. (HHS.gov)

Paused/limited:

• FDA cannot accept new submissions that require payment of a user fee (e.g., NDAs/BLAs/ANDAs, biosimilars, animal drug applications, device submissions with fees).
• Many routine inspections and longer-term policy and regulatory science projects are paused unless tied to carryover fees or life-safety needs. (HHS.gov)

Practical effect for sponsors: if your filing requires a fee, don’t attempt to submit today; the agency cannot accept it during the lapse. Time-sensitive interactions not tied to fees may still face delay.

Imports: FDA review and CBP operations

• CBP is open: Cargo processing and tariff collections continue, as inspection and law-enforcement functions are considered essential. Expect normal acceptance of entries but potential slower back-office actions (e.g., some audits/rulings) across trade agencies. (Reuters)
• FDA at the border: The agency continues import entry screening and high-risk exams to protect public health; routine throughput may slow if staffing is constrained. Prior Notice systems remain integral to targeting and exams. (HHS.gov)

Importers should anticipate longer exam/release timelines, especially for higher-risk commodities, and plan for contingencies if goods are flagged.

USDA snapshot—APHIS VS permits and FSIS inspections

• USDA APHIS (including VS) will continue activities supported by user fees, including animal import and export services, after-hours AQI services, and phytosanitary certifications. APHIS also continues animal/plant health emergency programs using no-year funds (e.g., HPAI, ASF). Routine activities funded solely by annual appropriations (e.g., some program ops, certain veterinary biologics reviews) cease during the lapse. (USDA)
• USDA FSIS food safety inspections (meat, poultry, egg products) continue as essential operations to protect public health. (USDA)

For VS permits (e.g., VS 16-3/16-6 series via APHIS eFile): processing that is fee-funded should continue, though users may still see slower turnaround due to broader staffing constraints elsewhere in the Department. (USDA)

Sponsor & Importer Checklist (actionable steps)

1. Hold fee-bearing FDA submissions until funding resumes; coordinate target dates with your reviewers. (HHS.gov)
2. Triage regulatory timelines: re-sequence milestones (e.g., PAIs/routine audits) likely to be delayed; keep “for-cause” readiness intact. (HHS.gov)
3. For imports, build slack into lead times; pre-clear documentation; ensure Prior Notice data quality; coordinate closely with your broker on port conditions. (Reuters)
4. Animal/biologic movements: if you rely on USDA VS permits, file promptly via APHIS eFile and flag any time-sensitive shipments; confirm whether your request is user-fee–funded (more likely to proceed). (USDA)
5. Communicate internally: update commercial, supply-chain, and quality teams on likely delays and what can still move (e.g., FDA import screening continues; FSIS inspections continue). (HHS.gov)

A note on timing and backlogs

Even where work continues, expect slower response times and growing queues. Once funding is restored, agencies typically prioritize life-safety and statutory-deadline work first, with catch-up on routine reviews and policy projects thereafter. Monitoring port conditions and center-specific communications remains critical. (HHS.gov)

Key sources we’re watching

• FDA (HHS) FY 2026 Contingency Staffing Plan – FDA (what continues/pauses; 86% staff retained; import entry review continues; user-fee submission acceptance paused). (HHS.gov)
• DHS/CBP statements confirming continued cargo processing and tariff collections during the shutdown. (Reuters)
• USDA Lapse of Funding Plan (FY 2026) detailing APHIS user-fee–funded continuity (animal import/export services) and FSIS essential inspections. (USDA)

If you have a time-critical filing, shipment, or permit need, reach out—we’ll help sequence next steps based on your facts and the latest center/agency posture.

• The Washington Post
• Reuters
• TIME
• Reuters
• apnews.com