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Day 33 Shutdown Update:

A Second Month Without Movement

The federal government shutdown has now reached Day 33, marking the start of its second month and solidifying its place as one of the longest funding lapses in U.S. history.

As the shutdown enters this new phase, the implications for FDA, USDA, and related regulatory bodies are no longer temporary—they are structural. Essential personnel remain overextended, user-fee reserves are nearing exhaustion, and the once-temporary backlog has hardened into a lasting disruption.

For companies in the food, drug, device, tobacco, and veterinary sectors, this moment represents a critical inflection point: the shutdown is no longer an interruption—it is a systemic pause in regulatory time.

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FDA Update: The End of Carryover

The Food and Drug Administration (FDA) continues to operate under contingency status. The agency has reiterated that it cannot accept new submissions requiring user-fee payments, including:

• NDAs, BLAs, ANDAs, and Supplements under PDUFA and GDUFA,
• 510(k)s, PMAs, and De Novo submissions under MDUFA,
• Animal drug and biosimilar applications under ADUFA and BsUFA,
• Tobacco-related PMTAs and SE reports under CTP’s User Fee Authority.

Carryover user-fee balances have funded limited review activity through October, but reports now indicate slowing internal coordination and review fatigue across several centers.
(FDA.gov – FY 2026 Lapse Plan)

As the second month begins, even active reviews are expected to decelerate, as overtime restrictions, contractor suspensions, and back-office furloughs take hold.

Key takeaway: user-fee continuity does not equal operational continuity—each week that passes erodes the system’s internal capacity to review, correspond, and finalize regulatory actions.

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Center for Tobacco Products (CTP): PMTA Review Gridlock

The Center for Tobacco Products (CTP) is now effectively frozen.

• New PMTA submissions are not being accepted, and previously filed applications remain unreviewed.
• Enforcement monitoring of unauthorized tobacco and nicotine products has paused, including follow-up to pre-shutdown warning letters.
• Market authorization delays are creating uncertainty for both combustible and e-vapor product manufacturers, who depend on FDA determinations for retail compliance.

Implication: The regulatory vacuum may lead to an uptick in unauthorized product distribution, as the usual cadence of warning letters and import detentions has halted.

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Center for Veterinary Medicine (CVM): Animal Health on Hold

The Center for Veterinary Medicine (CVM) continues to operate at minimal staffing. Only safety-related animal drug reviews remain active.

• No new ADUFA or AGDUFA submissions are being accepted.
• Ingredient approvals and pet-food consultations are suspended.
• Import reviews for medicated feeds and veterinary products are delayed several days at major ports.

This shutdown period is particularly disruptive to the pet and livestock sectors, where seasonal product launches and feed reformulations depend on predictable FDA review windows.

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USDA: SNAP Halt and Agricultural Paralysis

The U.S. Department of Agriculture (USDA) confirmed that federal food-aid benefits (SNAP) will not be issued for November without appropriations.
(NBC Chicago, Oct 28, 2025)

This announcement highlights the economic reach of the shutdown: disruptions now extend beyond compliance and into food access, impacting grocers, distributors, and suppliers across the U.S. food chain.

Meanwhile, FSIS and APHIS remain under reduced staffing, delaying inspections and permitting for agricultural exports and imports. Partial field-office reopenings remain limited to pre-approved financial assistance functions, not regulatory oversight.

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The Broader Impacts: A System Drifting Out of Sync

• Federal Register: Regulatory notices remain suspended; all comment periods continue to expire unacknowledged.
• FDA Systems: DailyMed, Enforcement Reports, and Warning Letter databases are static and outdated.
• Imports: FDA/USDA dual-jurisdiction entries are now delayed 4–8 days at primary ports.
• Courts and FOIA: Case management for regulatory litigation continues to slow due to judiciary furloughs.

What once appeared to be a pause in operations is now transforming into a full loss of procedural alignment across federal systems.

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Compliance in the Second Month: What Companies Should Do

1. Maintain a digital audit trail.
Keep timestamped proof of all attempted submissions, payments, and correspondence.

2. Alert distributors and co-manufacturers.
Partners should be informed that FDA verification systems and import approvals are temporarily unreliable.

3. Prioritize post-restart filings.
Prepare resubmission packets now—agencies will triage work by urgency once operations resume.

4. Plan for selective restart and triage.
Expect FDA to prioritize safety, compliance, and enforcement before routine administrative filings.

5. Document reliance on pre-shutdown data.
Where decisions are made using outdated public databases (DailyMed, Enforcement Reports), document the reasoning for compliance continuity.

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Entering the Second Month: What It Means

The beginning of Month Two represents a new phase of the shutdown: not a temporary lapse, but a sustained degradation of federal capability.

• CTP’s regulatory authority is muted,
• CVM’s safety infrastructure is stretched thin, and
• USDA’s food-aid suspension connects policy failure directly to the dinner table.

For the regulated community, the goal is no longer just endurance—it is strategic documentation, ensuring that when the lights come back on, every compliance action taken during the shutdown can be justified and validated.

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FDA Atty will continue tracking FDA, USDA, CTP, and CVM operations as the shutdown moves into its second month. Updates will include any new appropriations actions, reopening guidance, or post-lapse reinstatement procedures issued by the agencies.