Day 30 Shutdown Update

Thirty days in, the shutdown has reached a threshold that few agencies were designed to withstand. What began as a temporary funding lapse has become an operational drought, and for several FDA centers—particularly the Center for Tobacco Products (CTP) and the Center for Veterinary Medicine (CVM)—the margin for continuity is disappearing.

The broader government remains without appropriations, and even as carryover user-fee balances stretch to their limits, the regulatory pipeline across multiple sectors has slowed to its weakest point since the COVID-19 suspension period of 2020.

FDA: The Slow Collapse of the Submission Cycle

The FDA’s official lapse-plan status remains unchanged:

• The agency cannot accept new submissions that require user-fee payments under any statutory program.
• Carryover user-fee funds continue to support only limited ongoing reviews, while non-user-fee work—including enforcement, compliance, and policy development—remains dormant.
  (FDA Lapse Plan, Oct 2025)

As of this week, most internal centers report dwindling operational bandwidth. Contractors have been released, cross-center coordination has stopped, and advisory committee scheduling is frozen.

Center for Tobacco Products (CTP): PMTA Stagnation and Compliance Gaps

The CTP, responsible for regulating tobacco and nicotine products, is experiencing one of the most severe slowdowns:

• Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) submissions have effectively stopped moving; no new filings can be accepted while user-fee processing is suspended.
• Enforcement reviews for unauthorized flavored and synthetic-nicotine products are paused; warning letters issued pre-shutdown remain unprocessed for follow-up.
• Import coordination through CBP continues only for detained or health-risk shipments.

For manufacturers and importers, this means regulatory uncertainty on two fronts: active applications are frozen, and unreviewed products remain in legal limbo.

Companies should maintain internal documentation of all PMTA or SE filings submitted before the shutdown, noting receipt acknowledgments and payment confirmations. Once appropriations resume, CTP will likely triage reviews by public-health priority, delaying less-critical or small-volume submissions well into 2026.

Center for Veterinary Medicine (CVM): Disruption in Animal Health Regulation

The CVM continues to operate under severely restricted funding. While a minimal team supports emergency animal-drug safety functions, nearly all other activities are on hold:

• Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) submissions cannot be accepted.
• Feed and supplement reviews, including pet-food ingredient consultations, are paused.
• Import reviews for veterinary products—particularly dual-jurisdiction supplements and medicated feeds—face multi-day delays.

This gap affects both the companion-animal and livestock sectors. Ingredient suppliers awaiting new approvals for pet-nutrition products should expect that review timelines will reset entirely once staff return.

USDA: Aid Frozen, Oversight Thinned

The USDA’s statement earlier this week confirmed that SNAP and other food-aid benefits will not be issued beginning November 1 without appropriations.
(NBC Chicago, Oct 28 2025)

Meanwhile, APHIS and FSIS remain on minimal staffing. Permitting, inspection certification, and grant renewals are still frozen. Partial field-office reopenings have not restored the regulatory backbone necessary for import/export verification.

The Broader Shutdown Map:

• FDA’s data systems—including DailyMed, Regulations.gov, and Enforcement Reports—remain static.
• Court and FOIA activity continue to slow as judiciary furloughs widen.
• Registration renewals across food, drug, cosmetic, and tobacco programs are accepted but unvalidated.
• Import clearance delays average 3–7 days for dual-agency goods.

Outlook: The Era of Diminishing Returns

At Day 30, the federal regulatory system is not only paused—it is degrading. Each center now operates in isolation, sustained by residual funds and overextended staff. The CTP’s stagnation threatens market compliance; CVM’s silence jeopardizes animal-health innovation; and the FDA’s broader pipeline is sliding into an administrative recession.

Recommended Actions:

1. Document every pending or attempted filing—keep receipts, timestamps, and transaction logs.
2. Communicate proactively with downstream partners (importers, distributors, labelers) about likely restart delays.
3. Prioritize critical filings—public-health, safety, or contractual obligations will take precedence when triage begins.
4. Plan for selective recovery—expect PMTA, NADA, and ADUFA programs to resume gradually, not all at once.

Thirty days into the shutdown, the cracks between policy and practice have become chasms. The system still exists—but only on paper.

FDA Atty will continue monitoring each center’s operational signals, user-fee balance updates, and any interim guidance issued once appropriations negotiations resume.