FDA Import Requirements: How to Avoid Detention and Refusal

Which Products Does FDA Regulate at Import?

The US Food and Drug Administration regulates a broader range of imported products than many importers realize. FDA's jurisdiction covers human food and beverages (including dietary supplements), animal food and feed, human drugs (prescription and over-the-counter), biological products, medical devices, cosmetics, tobacco products, and electronic products that emit radiation (such as laser devices and microwave ovens). Approximately 40% of all food consumed in the United States is imported, and FDA-regulated imports account for a significant share of all US inbound shipments.

Unlike CBP, which processes all imports, FDA focuses its enforcement on products that pose potential health and safety risks. FDA's approach is risk-based: products from countries, manufacturers, or product categories with poor compliance histories receive more scrutiny. Understanding where your products fall on FDA's risk spectrum is the first step in developing a compliance strategy.

Prior Notice: Your First FDA Obligation

For food and food-related products, FDA requires prior notice of every import shipment. Prior notice must be submitted to FDA electronically before the product arrives at the US port of entry. The timing requirements vary by mode of transport: 15 days but no more than 30 days before arrival for food arriving by water; 4 hours for food arriving by air or rail; and 2 hours for food arriving by land. Prior notice is submitted through the FDA Prior Notice System Interface (PNSI) or through the Automated Broker Interface (ABI) as part of the customs entry.

• Required data elements: Identification of the article (FDA product code, common name), manufacturer/shipper, grower (for raw agricultural commodities), country of origin, country from which shipped, anticipated arrival information, name and address of importer/consignee, and the carrier.
• Failure to file: Products offered for import without prior notice or with inadequate prior notice are subject to refusal of admission and may be held at the port.
• Amendments: Prior notice can be amended, but the original must be filed within the required timeframes. Late amendments do not cure a late initial filing.

FSVP: The Foreign Supplier Verification Program

The Foreign Supplier Verification Program (FSVP) is a FSMA (Food Safety Modernization Act) requirement that places the burden on US importers to verify that their foreign suppliers produce food in a manner that provides the same level of public health protection as US food safety standards. FSVP applies to every importer of food for human or animal consumption, with very limited exceptions.

Under FSVP, importers must perform a hazard analysis of each food they import, evaluate the risk posed by each food and supplier, determine and conduct appropriate verification activities (such as onsite audits, sampling and testing, or reviewing the supplier's food safety records), and take corrective actions when necessary. Verification activities must be documented and records retained for at least two years.

Key FSVP Compliance Requirements

• Qualified Individual: FSVP activities must be performed by a 'qualified individual' who has the education, training, or experience necessary to perform the activities. This does not require a specific credential, but the individual must be demonstrably qualified.
• Supplier approval: You must approve each foreign supplier before importing their food, based on your hazard analysis and evaluation of the supplier's performance and procedures.
• Ongoing verification: FSVP is not a one-time exercise. You must conduct verification activities on an ongoing basis, with frequency determined by the risk level of the food and supplier.
• Corrective actions: If verification reveals that a supplier is not meeting food safety standards, you must take corrective actions — which may include discontinuing the use of that supplier.
• Record keeping: Maintain records of hazard analyses, supplier evaluations, verification activities, and corrective actions. FDA inspectors will request these records during facility inspections or import examinations.

Import Alerts and DWPE: The Detention System

FDA import alerts are published notices that instruct FDA field staff to detain shipments of specific products from specific countries, regions, or manufacturers without physical examination. This mechanism is called Detention Without Physical Examination (DWPE), and it is FDA's primary tool for blocking non-compliant imports. When your product or supplier is listed on an import alert, every shipment is automatically detained — meaning it cannot be released into US commerce until you demonstrate compliance or the product is refused and destroyed or re-exported.

There are over 100 active import alerts covering a wide range of products and countries. Common triggers include pesticide residue violations in produce, pathogen contamination in seafood, undeclared allergens in processed foods, unapproved drug ingredients in dietary supplements, and manufacturing quality failures in medical devices. Each import alert specifies the reason for detention and the products or firms covered.

How to Check If Your Product Is on an Import Alert

• FDA Import Alert website: Visit the FDA Import Alerts page and search by product type, country, or alert number. The database is updated regularly and is publicly accessible.
• Search by manufacturer: Each import alert lists specific firms on either a 'red list' (detention applies) or a 'green list' (exempt from detention). Check whether your foreign supplier appears on any relevant red lists.
• Check OASIS: FDA's Operational and Administrative System for Import Support (OASIS) contains line-level data on import decisions. Your customs broker may have access to query OASIS for historical detention data on your products.
• Subscribe to updates: FDA publishes updates to import alerts regularly. Subscribe to FDA's import alert notification system to be alerted when your product categories or supplier countries are affected.

Responding to an FDA Detention

When a shipment is detained, you have several options. You can provide evidence to overcome the appearance of a violation — such as laboratory test results showing the product meets FDA standards, certificates from accredited third-party laboratories, or documentation showing the product was manufactured under adequate controls. If FDA finds your evidence persuasive, the shipment may be released. If not, the product is formally refused admission, and you must either re-export it or destroy it under FDA supervision within 90 days.

For firms placed on a DWPE list, removal requires demonstrating a sustained track record of compliance. This typically involves submitting multiple consecutive shipments with clean laboratory results, providing evidence of corrective actions at the manufacturing facility, and sometimes undergoing an FDA facility inspection. The process can take six months to over a year, and there is no guarantee of removal.

Working with FDA to Achieve Compliance

• Engage early: If you know your product category is subject to heightened scrutiny, proactively obtain third-party laboratory testing and quality certifications before your first shipment arrives.
• Use FDA-recognized accredited labs: Laboratory results carry more weight with FDA when they come from labs accredited under the Accredited Third-Party Certification Program or ISO 17025-accredited facilities.
• Build a compliance file: For each product, maintain a file containing manufacturing specifications, ingredient lists, allergen declarations, Good Manufacturing Practice (GMP) documentation, and test results. This file is your defense when FDA questions a shipment.
• Consider the Voluntary Qualified Importer Program (VQIP): VQIP provides expedited review and entry for importers who meet FDA's qualification criteria. Participation requires a strong compliance history and use of accredited third-party auditors, but the benefits — faster release times and reduced examinations — are substantial for high-volume food importers.
• Maintain communication with your customs broker: Your broker's FDA experience matters. A broker familiar with FDA processes can file proper prior notice, respond quickly to detentions, and advise on the most effective strategy for achieving release.

How Camtom Supports FDA Compliance

Camtom's compliance platform helps importers navigate FDA requirements by flagging products that require prior notice, identifying FDA product codes during the classification process, and alerting you when your products or suppliers appear on active import alerts. By integrating FDA compliance checks into your standard import workflow, Camtom reduces the risk of detention and keeps your FDA-regulated shipments moving through the port without unnecessary delays.

“The best time to address FDA compliance is before your shipment arrives at the port. The worst time is when you receive a detention notice and your goods are sitting in a bonded warehouse accumulating storage fees.”

— Camtom Team