You bring products to the U.S. market and face a complex set of rules from the FDA that affect labeling, documentation, inspections, and whether your shipment clears customs. Understand the FDA imports control and documentation requirements to avoid costly holds, detentions, or refusals at the port of entry.
This article explains how the FDA screens and inspects imports, what declarations and prior notices you must submit, and how enforcement actions work so you can prepare shipments that meet regulatory expectations. You will get practical guidance on the import process and compliance steps that reduce delays and protect your market access.
FDA Imports Process
You must meet specific registrations, submit accurate entry documentation, and respond quickly if the FDA import flags or detains your shipment. Timely communication with Customs brokers and having required records ready reduces delays and risk of refusal.
Regulatory Requirements for Imported Goods
You are responsible for ensuring imported products comply with applicable FDA statutes and regulations before shipment arrives. Key requirements include facility registration, product-specific filings (for example, LACF for low-acid canned foods, HACCP records for seafood/juice), and an established Foreign Supplier Verification Program (FSVP) when required.
Prior Notice must be submitted for most food shipments to allow FDA review before arrival. You should also verify product labeling, ingredient declarations, and any safety standards or tolerances (e.g., drug or pesticide residues) that apply to your commodity.
Consider traceability obligations under FSMA 204 for certain high-risk foods, and check for participation in voluntary programs like VQIP if eligible. Maintain digital and physical records (supplier documents, testing, certificates) because FDA or CBP can request them during entry review or inspection.
Entry Review and Documentation
You or your customs broker submit the electronic entry to CBP; CBP forwards FDA-regulated entry data to FDA for screening. Provide accurate Harmonized Tariff Schedule codes, product descriptions, manufacturer and shipper details, and any required attachments (prior notice, facility registration, FSVP attestations).
FDA’s automated screening may release the entry, sample it, or flag it for further review. If flagged, FDA will request additional documentation such as certificates of analysis, manufacturing records, or proof of compliance with specific standards. Respond promptly; delays in submitting requested documents commonly lead to hold or refusal.
Use a checklist to avoid omissions:
- Prior Notice submitted (food)
- Facility registration active
- FSVP documentation available
- Product-specific filings (LACF, HACCP, etc.)
- Complete entry data and supporting attachments
Import Refusals and Detentions
FDA can place a shipment on hold based on the appearance of a violation or automated screening results. Your shipment may be detained, refused admission, or subject to sampling and laboratory testing if FDA suspects contamination, misbranding, or other violations.
You have rights to provide evidence to refute the apparent violation or to bring the product into compliance. Typical corrective actions include submitting laboratory test results, updated labeling, treatment or reconditioning, or exportation. Work with your broker and legal counsel to prepare and submit rebuttal evidence quickly.
Be aware of Import Alerts: if your product or supplier appears on an Import Alert list, FDA may detain future shipments without physical examination until you demonstrate corrective measures. Tracking alerts and maintaining compliant supplier documentation reduces the risk of repeated detentions.
Compliance and Enforcement for FDA Imports
You must meet documentary, facility, and product-specific requirements before shipment arrival. Expect inspections, possible sampling, and a formal admissibility decision that can include detention, refusal, or release with conditions.
Roles of Importers and Brokers
You hold primary responsibility for ensuring imported products meet FDA laws and regulations. That includes facility registration, product listing if applicable, and submission of Prior Notice for food shipments.
Use an experienced licensed customs broker to file entry documents, coordinate with U.S. Customs and Border Protection (CBP), and transmit FDA-required data elements correctly. Brokers do not replace your legal obligations; they execute filings and advise on tariff and entry specifics.
Maintain accurate records — manufacturing lots, certificates of analysis, labeling, and shipping manifests — for the statutory retention period. Prepare corrective documentation quickly when FDA or CBP requests it to avoid detention, redelivery, or enforcement action against your bond.
Inspection Procedures and Sampling
FDA inspects shipments at ports of entry and designated facilities. Inspections can include document reviews, physical examination, and collection of samples for laboratory analysis. You should expect personnel to verify labeling, ingredient lists, and compliance with applicable standards (e.g., cGMP for drugs, HACCP/FSMA for foods).
When FDA samples product, they follow chain-of-custody and testing protocols; results determine further action. You can request an administrative or laboratory appeal if test results or procedures appear flawed. Respond promptly to 801(b) or Notice of Detention correspondence to preserve appeal rights and reduce storage costs.
Product Admissibility Determination
FDA uses inspection and test results to decide whether to admit, detain without physical examination, or refuse entry for a product. Common grounds for refusal include adulteration, misbranding, unapproved active ingredients, and missing prior notices or registrations.
If FDA detains or refuses a shipment, you may arrange redelivery, reexportation, destruction, or pursue a regulatory hearing or voluntary compliance plan. Understand timeframes: respond to Detention Notices within the specified period and coordinate bond actions if CBP initiates enforcement against your import bond.
