How US Customs and Border Protection Works With the FDA to Screen Imported Products

When a container of FDA-regulated products arrives at a US port, it does not pass through FDA review alone. The US Customs and Border Protection (CBP) and the FDA operate an integrated import screening system that evaluates every shipment before it can be released into US commerce. CBP controls the physical border — inspecting containers, collecting duties, and enforcing trade laws — while the FDA exercises regulatory authority over the safety, labeling, and compliance of food, drugs, medical devices, cosmetics, and other products within its jurisdiction. For foreign manufacturers, understanding how these two agencies interact is essential for avoiding delays, detentions, and refusals at the port.

The Automated Commercial Environment and FDA integration

All import entries into the United States are filed through the Automated Commercial Environment (ACE), the electronic system operated by CBP that processes trade data. When an entry is filed for an FDA-regulated product, ACE automatically routes the entry information to the FDA for review. The FDA uses this data — combined with information from Prior Notice filings (for food), facility registration records, import history, and risk-scoring algorithms — to determine whether the shipment should be released, examined, sampled, or detained. This electronic integration means that a shipment can be flagged by the FDA before it physically arrives at the port, and that compliance problems in the electronic filing can prevent clearance even if the product itself is perfectly compliant.

FDA's PREDICT risk-scoring system

The FDA uses the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to assign risk scores to import entries. PREDICT evaluates multiple factors including the product type, the country of origin, the manufacturer's compliance history (including previous violations, Warning Letters, and import alerts), the importer's compliance history, and whether the product falls within a category associated with known safety concerns. Higher-risk entries are flagged for physical examination, sample collection, or laboratory analysis, while lower-risk entries may be released without examination. A manufacturer's PREDICT score is not static — it improves with a clean compliance history and worsens with each violation, creating a strong incentive for consistent compliance.

Physical examination and sampling at the port

When a shipment is flagged for FDA examination, the product may be subjected to label review (visual inspection of the label for compliance with US requirements), physical examination (inspection of the product's condition, packaging, and overall appearance), and sample collection for laboratory analysis (testing for contaminants, pathogens, undeclared ingredients, or potency). During this process, the shipment is held at the port or in a bonded warehouse, and the importer bears the costs of storage, demurrage, and any handling required for examination. Laboratory analysis can take days to weeks depending on the tests required, and the shipment remains in hold status until the FDA makes a final admissibility determination.

Detention, refusal, and the right to a hearing

If the FDA determines that a product appears to be in violation of the FD&C Act — adulterated, misbranded, or otherwise non-compliant — the agency issues a Notice of FDA Action detailing the violations and proposing refusal of admission. The importer has the right to submit evidence that the product is not in violation (known as providing 'testimony' or 'evidence of compliance') and may request an informal hearing. If the FDA is not persuaded by the importer's evidence, the product is formally refused admission and must be exported or destroyed within 90 days at the importer's expense. Refused shipments are recorded in the FDA's import database and contribute to the manufacturer's compliance history, affecting PREDICT scores for future shipments.

The role of the customs broker

Licensed US customs brokers serve as intermediaries between the importer and CBP/FDA, handling the entry filing, Prior Notice submission (for food), document management, and communication with both agencies. A knowledgeable customs broker who understands FDA requirements can prevent many common filing errors — incorrect product codes, missing Prior Notice, wrong manufacturer information, or inaccurate entry data — that cause unnecessary delays and examinations. Foreign manufacturers should ensure that their US importers use customs brokers experienced with FDA-regulated products, as the quality of the entry filing directly affects how smoothly the shipment clears.

How FDABridge helps with import compliance

FDABridge ensures that your FDA registrations — food facility registration, drug establishment registration, or MoCRA cosmetics registration — are current and accurate, which is the foundational requirement for smooth import clearance. Products from registered facilities with clean compliance histories receive more favorable PREDICT scores and face fewer delays at the port. Visit fdabridge.com to see our registration services or fdabridge.com/contact to discuss your compliance needs.