How the FDA continues to function during a government shutdown
Benjamin England explains that while the phrase “government shutdown” often causes alarm, these events are not uncommon. Drawing from his experience at the FDA, he shares that the agency continues to operate at approximately 86 percent capacity, largely because many FDA functions are funded by user fees paid by private industry rather than congressional appropriations.
Drug and medical device approvals, for instance, are supported by application fees paid by companies seeking FDA clearance. Because these funds are not tied to federal budgets, the personnel who process and review those applications continue to work. Compliance operations—including those that directly affect imports—remain active as well.
Benjamin notes that import oversight has always been considered essential work for the FDA. With a vast portion of the U.S. food and drug supply chain dependent on imports, inspectors and compliance officers remain at their posts. Although most domestic and foreign facility inspections are suspended unless linked to a safety emergency, border inspections and import screenings continue for foods, cosmetics, drugs, and medical devices.
Why high-risk imports receive top priority
Benjamin England emphasizes that this is not a time for companies to “slip products through the cracks.” Both the FDA and U.S. Customs and Border Protection (CBP) remain largely staffed, and their electronic screening systems continue operating as usual. These systems automatically flag and review shipments based on historical data and product risk.
He explains that the FDA relies on an internal risk-based matrix that prioritizes inspections by safety category. High-risk products, such as ready-to-eat foods that will not undergo further processing, remain the top focus. Items like seafood are also heavily scrutinized due to concerns about contamination, including incidents of seafood tainted with Cesium-137, a radioactive compound.
In contrast, lower-risk categories—such as bulk ingredients, low-risk foods, and some non-ingestible items—may see fewer examinations during the shutdown. However, the FDA continues to conduct labeling reviews, a relatively low-cost activity that ensures companies maintain compliance with labeling and ingredient declaration requirements.
How the shutdown affects communication with FDA and Customs
According to Benjamin England, importers may notice slower communication and longer review times. When a shipment is held for examination, the initial notification typically comes from the agency’s automated system. Importers are then asked to submit additional documentation or clarification.
During a shutdown, automated replies often inform companies that “due to limited staffing, responses may take several days or weeks.” Benjamin cautions that delays can extend well beyond normal timelines, as agencies reduce screening rates for low-risk products to conserve resources for higher-risk ones.
He advises importers to follow up actively rather than wait indefinitely. Phone calls and direct emails to compliance officers can help ensure cases remain visible. For companies whose products are wrongfully delayed, experienced counsel can sometimes persuade agencies to reevaluate the risk classification and release shipments more quickly.
How serious health emergencies are handled during the shutdown
Even with reduced operations, Benjamin England explains that public health emergencies remain top priority. If a product in the market poses a serious health risk—such as a contaminated food or drug—the FDA and Customs coordinate to trace, recall, and detain affected goods.
He describes how agencies conduct traceback investigations to determine both the source and distribution path of the contaminated product. For instance, if contaminated seafood is discovered, regulators will sample and test similar imports for radioactive contamination, halting potentially dangerous cargo until results confirm safety.
Benjamin emphasizes that these functions continue because they are categorized as essential activities protecting public health. Despite not being paid during the shutdown, many federal employees continue working out of dedication to the mission, helping prevent unsafe products from reaching consumers.
The role of Customs and how inspections continue under DHS
Benjamin England details how CBP, part of the Department of Homeland Security, operates at near-full capacity even during funding lapses. Customs inspectors at ports of entry continue performing physical inspections and managing import enforcement.
While CBP’s enforcement and inspection divisions remain active, certain administrative functions—such as financial penalty cases or long-term damage claims—may experience delays due to limited staff. Enforcement efforts instead prioritize critical activities, including FDA and USDA-regulated goods, as well as security-related issues such as drug smuggling or counterfeit products.
Benjamin notes that joint operations between CBP, FDA, and USDA continue for meat and poultry imports, as these inspections are mandatory by law. In contrast, inspections for non-essential issues, such as intellectual property disputes, slow considerably during the shutdown period.
What importers should expect once the government reopens
When the government reopens, Benjamin England warns that agencies face a significant backlog. Work that was paused—especially for lower-risk imports—must still be completed. As a result, the recovery period often extends far beyond the official reopening date.
He also predicts staff shortages, as some employees may leave government service during prolonged shutdowns. These vacancies exacerbate existing delays, making it essential for companies to remain patient but persistent.
Benjamin advises importers to stay proactive. Submissions and inquiries should continue even if responses are slow. Once operations resume, those who have maintained communication will be first in line for review. He stresses that in dealing with federal agencies, the squeaky wheel gets the grease—consistent, respectful follow-ups can make a meaningful difference.
Finally, he points out that customs brokers, while valuable partners, often hesitate to press agencies aggressively since they work with them daily. Importers may benefit from engaging regulatory counsel familiar with government processes, whose role is to advocate assertively and ensure the company’s shipments receive attention.
Key takeaway: Preparation and persistence pay off
Benjamin England concludes that while shutdowns create uncertainty, the FDA and Customs continue operating in critical areas to protect public health. For importers, the most effective strategy is preparation—understanding how the agencies prioritize risk, maintaining documentation, and communicating consistently throughout the delay.
Once the shutdown ends, companies should expect lingering backlogs and slower processing times, but by staying organized and proactive, they can minimize disruption. As Benjamin reminds listeners, knowledge of the system and persistence in communication are the keys to navigating regulatory challenges, even during government downtime.
If you’re facing challenges with importing FDA-regulated products, we’re here to help you navigate the process smoothly. Let us be your guide through the complexities of trade tariffs, FDA compliance, and border issues. Visit us at FDAImports or contact us directly at contact@fdaimports.com for assistance.
This news update is provided for informational and educational purposes only and does not constitute legal advice and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
