FDA Import Detention Response Playbook

What Is FDA Import Detention?

FDA import detention occurs when an article of food offered for import appears to violate the Federal Food, Drug, and Cosmetic Act. Detention is not a final refusal — it is a temporary hold that gives the importer an opportunity to present evidence or take corrective action. However, if the detention is not resolved, FDA will issue a formal refusal of admission.

Detention can be triggered by physical examination at the port, laboratory analysis, import alert coverage, prior notice violations, or the absence of proper documentation (such as FSVP records or facility registration).

Types of Detention Actions

Immediate Steps After Detention

When you receive a detention notice, take these immediate steps:

• Review the Notice of Detention: Read the specific charges and identify the alleged violation. The notice will cite the section of the FD&C Act allegedly violated.
• Contact your customs broker: Ensure they are aware of the detention and can coordinate with FDA on logistics
• Assess your options: Determine whether to contest the detention, recondition, re-export, or destroy the shipment
• Gather documentation: Begin collecting evidence that may support your case (test results, certificates of analysis, manufacturing records)
• Note the deadline: You typically have 10 business days to respond to a detention notice

Requesting a Hearing

The importer, owner, or consignee can request an informal hearing with FDA to present evidence that the food is not in violation. The hearing is called "informal" because it is less formal than a courtroom proceeding, but it is the primary opportunity to challenge the detention.

• Submit a written request for hearing within the timeframe specified in the detention notice
• Identify the specific charges you are contesting
• Describe the evidence you intend to present
• The hearing is typically conducted by phone or in writing with the local FDA district office

Presenting Evidence to FDA

Your evidence package should directly address the specific charges in the detention notice:

• Laboratory test results: Independent testing from an FDA-recognized or ISO 17025 accredited laboratory showing the product is compliant
• Certificates of Analysis (COAs): Supplier COAs supplemented by your own or third-party testing
• Manufacturing records: Batch records, processing records, and food safety plan documentation
• Corrective action documentation: If a specific violation occurred, evidence of corrective and preventive action
• Label corrections: If the detention is for misbranding, corrected labels demonstrating compliance

Reconditioning and Re-export Options

Reconditioning

If the product can be brought into compliance through reconditioning (relabeling, sorting, reprocessing), you may apply to FDA for permission. FDA must approve the reconditioning plan before work begins, and the reconditioning must be supervised by an FDA investigator.

Re-export

You may request to re-export the detained product to a country other than the United States. FDA may grant this request, but you are responsible for all costs of re-export.

Destruction

If the product cannot be reconditioned or re-exported, it must be destroyed under FDA supervision. You bear all costs of destruction.

Timeline and Deadlines

• Day 0: Detention notice issued by FDA
• Days 1-10: Submit hearing request and initial evidence
• Days 10-30: FDA reviews evidence; may request additional information
• Days 30-90: FDA decision on release, refusal, or reconditioning
• If refused: You have 90 days from refusal to export or destroy the product

Costs of Detention

Detention costs can escalate rapidly:

• Port storage/demurrage: $150-$500+ per container per day depending on the port
• Re-examination fees: Costs for FDA sampling and laboratory analysis
• Independent testing: $500-$5,000+ per sample for accredited laboratory analysis
• Reconditioning costs: Labor, materials, and FDA supervision fees
• Product loss: Perishable goods may be destroyed if not released promptly
• Legal and consulting fees: Regulatory counsel and compliance consultant costs

How Assurentry Can Help

Assurentry provides detention response and prevention services:

• Emergency response: Rapid assessment and strategy development for detained shipments
• Evidence preparation: Building comprehensive evidence packages for FDA hearings
• Import alert removal: Long-term strategy for getting off import alerts
• FSVP compliance: Preventive programs to avoid future detentions
• Registration management: Ensuring all regulatory filings are current and accurate