Importing Food Products into the United States — FDA Compliance Guide
This guide covers every FDA requirement for food importers and foreign food manufacturers — what's required, who is responsible for each obligation, the specific regulations, and the step-by-step entry process.
FDA Food Import Requirements — Who Is Responsible for What
Food importation involves two distinct parties with separate and independent FDA obligations — the foreign manufacturer and the U.S. importer. Neither party's compliance substitutes for the other's. The table below shows every requirement, who owns it, and the governing regulation.
| Requirement | Responsible Party | Regulation | Notes |
|---|---|---|---|
| FDA Food Facility Registration | Manufacturer | 21 CFR Part 1 | Required before first shipment. Biennial Renewal Oct 1–Dec 31, even years. Foreign facilities need U.S. Agent. |
| U.S. Agent Designation | Manufacturer | 21 CFR Part 1 | Required for all foreign facilities. Must be physically located in the U.S. and actively responsive. |
| FSVP — Foreign Supplier Verification Program | U.S. Importer | 21 CFR Part 1 Subpart L | Separate program per foreign supplier. Must be in place before first import. Includes hazard analysis and verification activities. |
| FDA Prior Notice | Both parties coordinate | 21 CFR Part 1 Subpart I | Filed by importer or their agent before shipment arrives. Must include manufacturer's FDA registration number. |
| FDA-Compliant Labeling | Both parties coordinate | 21 CFR Part 101 | Manufacturer produces the label; importer verifies compliance before importing. Non-compliant labels = misbranding. |
| FSMA Preventive Controls | Manufacturer | 21 CFR Part 117 | Written Food Safety Plan required. FSVP verifies the supplier's compliance from the importer's side. |
| Seafood HACCP (seafood only) | Manufacturer | 21 CFR Part 123 | Required for seafood processors in addition to general food safety requirements. FSVP must verify seafood HACCP compliance. |
| FCE/SID (canned low-acid foods only) | Manufacturer | 21 CFR Part 113 | Food Canning Establishment registration and Scheduled Process filing for thermally processed low-acid canned foods. |
Each FDA Requirement Explained
1. FDA Food Facility Registration
Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with FDA under 21 CFR Part 1. This requirement was established by the Bioterrorism Act of 2002 and strengthened by FSMA. The registration is submitted through FDA's Unified Registration and Listing System (FURLS) and must be completed before the facility's first export to the United States.
The registration requires the facility's legal name and physical address, the owner/operator name, a DUNS Number (Unique Facility Identifier), declared food product categories, and the designation of a U.S. Agent. Registrations must be renewed during the Biennial Renewal window — October 1 through December 31 of every even-numbered year. A facility with a cancelled or lapsed registration cannot legally export food to the U.S. until it re-registers.
FDA Registration Assistance handles the complete Food Facility Registration process — including DUNS Number procurement, registration submission, U.S. Agent designation, and Biennial Renewal management — with most Food Facility Registrations confirmed within 24 to 48 hours of documentation being provided.
2. U.S. Agent
All foreign FDA-registered food facilities must designate a U.S. Agent with a physical U.S. address. The U.S. Agent is FDA's official domestic contact for the foreign facility — receiving inspection notices, import alerts, safety communications, and regulatory correspondence on the facility's behalf. The U.S. Agent must be available and responsive during U.S. business hours.
A nominal U.S. Agent — a name on a form that doesn't actively respond — creates serious compliance risk. If FDA sends an inspection notice or compliance communication and receives no response from the U.S. Agent, the facility may be considered non-cooperative, which can escalate to Import Alert placement. FDA Registration Assistance provides a responsive, active U.S. Agent service from Miami, Florida, for foreign food facilities in 135+ countries.
3. Foreign Supplier Verification Program (FSVP)
FSVP under 21 CFR Part 1 Subpart L is the U.S. importer's independent obligation to verify that each foreign food supplier is producing food that meets U.S. food safety standards. A separate FSVP must be maintained for every foreign supplier. FSVP must include:
Hazard analysis — identifying biological, chemical, and physical hazards that are reasonably likely to occur in the imported food, and whether those hazards require supplier verification. The hazard analysis must be specific to the food product and the supplier's processes.
Supplier verification activities — based on the hazard analysis, the importer must conduct verification activities proportionate to the risk. For hazards that could cause serious harm, this typically means annual onsite audits or product testing. For lower-risk hazards, review of supplier food safety records may be sufficient.
Recordkeeping — all FSVP documentation must be maintained for at least two years and made available to FDA upon request. Records must include the hazard analysis, supplier verification activity results, and any corrective actions taken when issues were identified.
Many U.S. importers do not realize FSVP is their independent obligation — separate from whether the foreign facility is registered with FDA. FDA Registration Assistance builds and maintains FSVP programs for U.S. importers sourcing from foreign food suppliers.
4. FDA Prior Notice
FDA Prior Notice under 21 CFR Part 1 Subpart I must be submitted before every food shipment arrives at a U.S. port of entry. Prior Notice can be filed through FDA's Prior Notice System Interface (PNSI) or through the CBP ACE portal. The submission must include:
Product description and FDA product code; the FDA registration number of the manufacturing facility; name and address of the manufacturer, shipper, and importer; anticipated port of entry; anticipated arrival date and time; and the entry type. The Prior Notice must accurately reflect the actual manufacturer — not a trading intermediary. A Prior Notice that names the wrong manufacturer, omits the FDA registration number, or describes the product inaccurately can result in shipment refusal even if all other compliance is in order.
5. FDA-Compliant Food Labeling
All imported food products must comply with FDA food labeling requirements under 21 CFR Part 101. A non-compliant label makes the product misbranded under 21 U.S.C. § 343 and grounds for refusal of admission at the port. The most common labeling deficiencies on imported food products are: using a foreign nutrition label format instead of FDA's Nutrition Facts panel; using the pre-2016 Nutrition Facts format; missing allergen declarations; and net quantity not expressed in U.S. customary and metric units. Label review before production is far less expensive than relabeling at the port.
How the FDA Food Import Process Works — Step by Step
The following sequence covers every step from first contact with an importer through successful port entry. Completing these steps in order — before the first shipment — prevents the detention and refusal issues that arise when companies try to establish compliance retroactively.
Register the Manufacturing Facility with FDA
The foreign manufacturing facility must register with FDA before the first export. This requires a DUNS Number, which must be obtained from Dun & Bradstreet first if the facility does not already have one. The registration is submitted through FURLS and designates FDA Registration Assistance as the U.S. Agent. Registration is typically confirmed within 24–48 hours of documentation being provided.
U.S. Importer Builds the FSVP Program
The U.S. importer develops an FSVP program for the foreign supplier under 21 CFR Part 1 Subpart L. This includes a hazard analysis specific to the food product, selection of appropriate supplier verification activities based on risk, and a recordkeeping system. FSVP must be complete before the first import — not retroactively after a shipment has already departed. FDA Registration Assistance builds FSVP programs for U.S. importers.
Review and Finalize the Product Label
The product label is reviewed against 21 CFR Part 101 before artwork is finalized and packaging is printed. The review covers Nutrition Facts panel format and accuracy, allergen declarations, ingredient list order and format, net quantity expression, statement of identity placement, and responsible party information. A label review at this stage prevents far more expensive relabeling at the port.
File FDA Prior Notice Before the Shipment Arrives
Before the food shipment arrives at the U.S. port of entry, the importer or their customs broker files Prior Notice through PNSI or the CBP ACE portal. The Prior Notice must include the FDA registration number of the manufacturing facility, accurate product description with FDA product code, and expected arrival details. Prior Notice should be filed as early as possible — FDA recommends filing at least 8 hours before arrival by road, 4 hours before arrival at a land border crossing, and 4 hours before arrival by air for shipments traveling less than 12 hours.
CBP Entry and FDA Review at the Port
The importer's customs broker files the CBP entry at the port of arrival. CBP transmits the entry and Prior Notice to FDA. FDA's PREDICT risk-scoring system evaluates the shipment based on the facility's compliance history, product risk profile, active Import Alerts, and Prior Notice information. Most compliant shipments from registered facilities with clean histories are released without physical examination (known as "May Proceed"). If FDA selects the shipment for physical examination or sampling, CBP holds the shipment while FDA conducts the review — typically completed within a few business days at most ports.
Maintain Compliance for Every Subsequent Shipment
FDA compliance is not a one-time setup. Prior Notice must be filed before every shipment. FSVP records must be maintained and updated. The Biennial Renewal must be completed by December 31 of each even-numbered year. Labels must be updated when formulations change or labeling regulations are amended. FDA Registration Assistance provides ongoing compliance management — including Biennial Renewal tracking, U.S. Agent availability, and label review as needed.
Why Food Shipments Are Detained or Refused — and How to Prevent It
No FDA Registration
The most fundamental compliance failure. A food shipment from an unregistered facility will be refused admission at the U.S. port of entry under 21 U.S.C. § 381. There is no grace period — the facility must be registered before the first shipment departs. FDA Registration Assistance completes most Food Facility Registrations within 24–48 hours.
Missed Biennial Renewal
Missing the Biennial Renewal window (October 1 – December 31, even-numbered years) automatically cancels the registration. Facilities with cancelled registrations are functionally in the same position as unregistered facilities. An active, managed U.S. Agent service tracks renewal deadlines so this never happens.
No Prior Notice or Inaccurate Prior Notice
Failure to file Prior Notice, or filing Prior Notice with an incorrect manufacturer name, wrong FDA registration number, or inaccurate product description, results in automatic refusal of admission at the port. Prior Notice errors are among the most preventable compliance failures — they require careful attention to detail, not complex regulatory knowledge.
Non-Compliant Label
A product with a missing or non-compliant Nutrition Facts panel, missing allergen declarations, net quantity not in required format, or misleading claims is misbranded and can be refused at the port. Labeling errors are particularly costly because they often require relabeling or destruction of inventory already at the port.
No FSVP for the Importer
FDA has increased FSVP enforcement significantly since 2022. An importer without an FSVP program faces civil penalties under FSMA. Critically, an importer with no FSVP is importing from suppliers whose food safety practices have not been verified — creating both regulatory and product safety risk.
FDA Import Alert
A facility on FDA Import Alert faces Detention Without Physical Examination (DWPE) on all future shipments until the compliance issue is resolved and FDA grants removal from the alert. Import Alert removal requires documentation of the corrective action, a petition to FDA, and sometimes a facility inspection. FDA Registration Assistance provides Import Alert resolution assistance.
Import Food Products into the U.S. Without Delays
FDA Registration Assistance handles every FDA compliance requirement for food importers and foreign food manufacturers — Food Facility Registration, U.S. Agent service, FSVP compliance, label review, Prior Notice guidance, and ongoing compliance management.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. 1,000+ clients. 135+ countries. 15+ years of combined FDA regulatory experience.
Frequently Asked Questions — Importing Food into the United States
1. What FDA requirements apply to importing food into the United States?
Six core requirements: (1) FDA Food Facility Registration under 21 CFR Part 1; (2) U.S. Agent designation for the foreign facility; (3) FSVP compliance by the U.S. importer under 21 CFR Part 1 Subpart L; (4) FDA Prior Notice before each shipment arrives under 21 CFR Part 1 Subpart I; (5) FDA-compliant labeling under 21 CFR Part 101; and (6) FSMA food safety compliance under 21 CFR Part 117. Seafood and canned low-acid foods have additional requirements.
2. Does the foreign food manufacturer need to register with FDA?
Yes. Any foreign facility that manufactures, processes, packs, or holds food for importation into the United States must register with FDA and designate a U.S. Agent before the first shipment. Registration must be renewed every two years during the Biennial Renewal window — October 1 through December 31 of every even-numbered year. A lapsed registration blocks all U.S. shipments until re-registration is completed.
3. What is a U.S. Agent and is one required?
A U.S. Agent is a person or company physically located in the United States that serves as FDA's official domestic contact for a foreign FDA-registered food facility. U.S. Agent designation is mandatory for all foreign food facilities under 21 CFR Part 1. The agent must be actively responsive — an inactive agent creates enforcement risk if FDA communications go unanswered.
4. What is FSVP and who is responsible for it?
FSVP — the Foreign Supplier Verification Program — is the U.S. importer's independent obligation under 21 CFR Part 1 Subpart L to verify that each foreign food supplier meets U.S. food safety standards. A separate FSVP must be maintained per supplier. FSVP includes hazard analysis, supplier verification activities, and two-year recordkeeping. The foreign manufacturer's registration does not substitute for the importer's FSVP obligation.
5. What is FDA Prior Notice and when must it be filed?
FDA Prior Notice under 21 CFR Part 1 Subpart I must be filed before every food shipment arrives at a U.S. port of entry. It must include the manufacturer's FDA registration number, product description with FDA product code, shipper/importer information, and expected arrival details. It is filed through PNSI or the CBP ACE portal. Failure to file — or filing inaccurate Prior Notice — results in automatic refusal of admission.
6. What labeling is required on imported food products?
Imported food must comply with all FDA labeling requirements under 21 CFR Part 101: Nutrition Facts panel in the current 2016-updated format; statement of identity on the Principal Display Panel; net quantity in U.S. and metric units; ingredient list in descending weight order; allergen declarations under FALCPA/FASTER Act; and responsible party name and address. Labels must be in English. Non-compliant labels make the product misbranded.
7. What happens at the U.S. port of entry when a food shipment arrives?
CBP processes the customs entry and transmits Prior Notice to FDA. FDA's PREDICT risk-scoring system evaluates the shipment. Most compliant shipments from registered facilities are released without physical examination ("May Proceed"). If FDA selects a shipment for examination, CBP holds it while FDA reviews samples or documentation. If violations are found, FDA may refuse admission under 21 U.S.C. § 381.
8. What is an FDA Import Alert?
An FDA Import Alert places a foreign facility, product, or country on a list that subjects all future shipments to Detention Without Physical Examination (DWPE) — shipments can be detained at the port without individual inspection. Import Alerts are issued when FDA documents compliance violations. Removal from Import Alert requires resolving the underlying issue and petitioning FDA. FDA Registration Assistance provides Import Alert resolution assistance.
9. Can a shipment be refused even if the facility is registered with FDA?
Yes. Registration is one of several requirements. A shipment can be refused for: inaccurate Prior Notice; non-compliant labeling; adulteration or misbranding found on examination; an active Import Alert; product categories not matching the facility's registration; or FSVP non-compliance identified during an importer inspection.
10. What is Detention Without Physical Examination (DWPE)?
DWPE is an FDA enforcement mechanism applied through Import Alerts that allows FDA to detain shipments at the port without conducting individual physical inspections. Prior documented violations provide sufficient basis for detention. DWPE shipments are held until the importer provides evidence the specific shipment is compliant, or the facility successfully petitions FDA for Import Alert removal.
11. What food products are exempt from FDA Food Facility Registration?
Exempt facilities include: farms growing and harvesting raw produce; retail food establishments selling directly to consumers; nonprofit food establishments; fishing vessels that don't process fish beyond basic operations; and facilities regulated exclusively by USDA (meat, poultry, egg products). Most manufacturing, processing, packing, and holding facilities — foreign or domestic — are required to register.
12. What is the FSVP importer and how is it different from a customs broker?
The FSVP importer is the U.S. owner or consignee of the food at the time of entry — as defined at 21 CFR Part 1.500 — and is responsible for FSVP compliance. The customs broker handles CBP entry procedures but is not responsible for FSVP. Most importers use a customs broker for CBP filings and a separate compliance firm to build and maintain their FSVP program.
13. How long must FSVP records be maintained?
FSVP records must be maintained for at least two years from the date created, per 21 CFR Part 1.510. This includes hazard analysis documentation, verification activity records (audit reports, test results, food safety record reviews), and corrective actions. Records must be available to FDA upon request.
14. Does a U.S. importer need an FSVP for every foreign food supplier?
Yes. A separate FSVP must be developed and maintained for each foreign food supplier. If an importer sources from five different foreign facilities, it must maintain five separate FSVP programs. Modified FSVP requirements may apply when importing from suppliers under FDA-recognized equivalence agreements.
15. What are the penalties for importing food without FDA compliance?
Consequences include: refusal of admission at port; shipment detention; FDA Import Alert placement; civil penalties under FSMA; seizure of products in U.S. commerce; injunctions against continued importing; and criminal prosecution for willful violations. Storage fees, demurrage, destruction costs, and re-export costs on a single detained container typically exceed the annual cost of maintaining proper compliance.
16. What is the Bioterrorism Act and how does it relate to food imports?
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 established the FDA Food Facility Registration and Prior Notice requirements. It amended the Federal Food, Drug, and Cosmetic Act to give FDA advance notice of incoming food shipments and the ability to respond to food safety threats. FSMA (2011) subsequently strengthened these requirements and added FSVP.
17. Does FSMA apply to foreign food manufacturers exporting to the U.S.?
Yes. FSMA's Preventive Controls for Human Food rule (21 CFR Part 117) applies to foreign facilities manufacturing food for U.S. importation. The FSVP rule extends FSMA requirements to the foreign supply chain through the U.S. importer's verification obligations — U.S. importers must verify their foreign suppliers comply with FSMA standards.
18. What is the difference between the manufacturer and the importer of record for FDA purposes?
The manufacturer is responsible for FDA Food Facility Registration, U.S. Agent designation, and FSMA Preventive Controls compliance. The importer of record is responsible for FSVP compliance and filing Prior Notice. Both parties have independent FDA obligations — compliance by one does not substitute for the other.
19. Can a product be imported if the label is not FDA-compliant?
A non-compliant label makes the product misbranded under the Federal Food, Drug, and Cosmetic Act and grounds for refusal of admission at the port. Labels should be reviewed against 21 CFR Part 101 before production — relabeling inventory already at a U.S. port is expensive and time-sensitive. FDA Registration Assistance provides label review services before products enter the production stage.
20. How does FDA determine which imported food shipments to examine?
FDA uses its PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) system. Factors include the facility's compliance history, product risk profile, active Import Alerts, Prior Notice information, and country of origin risk signals. Most compliant shipments from facilities with clean histories are released without physical examination.
21. What is the Biennial Renewal for Food Facility Registration?
FDA Food Facility Registration must be renewed every two years during the Biennial Renewal window — October 1 through December 31 of every even-numbered year (2024, 2026, 2028). Missing the window automatically cancels the registration and blocks all U.S. food shipments until re-registration is completed.
22. Do seafood importers have additional FDA requirements?
Yes. Seafood importers must verify that foreign seafood suppliers comply with FDA Seafood HACCP regulations under 21 CFR Part 123 as part of their FSVP. Canned seafood processors may also require FDA Food Canning Establishment (FCE) registration and Scheduled Process (SID) filing under 21 CFR Part 113.
23. What documentation should a U.S. importer maintain?
A U.S. importer should maintain: the foreign supplier's FDA registration number and confirmation; FSVP program documentation including hazard analysis and supplier verification records (maintained at least 2 years); Prior Notice confirmation numbers for each shipment; copies of FDA-compliant product labels; certificates of analysis or food safety test results from the supplier; and CBP import entry documentation.
24. Can FDA Registration Assistance help both the foreign manufacturer and U.S. importer?
Yes. FDA Registration Assistance serves both parties. For foreign manufacturers: Food Facility Registration, U.S. Agent designation, Biennial Renewal management, and label review. For U.S. importers: FSVP program development and maintenance, supplier verification documentation, and import compliance guidance. Both parties having complete FDA compliance in place before the first shipment is the most effective way to ensure smooth port entry.
25. How do I get started with FDA compliance for food imports?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Foreign manufacturers should provide facility name, address, and product details. U.S. importers should provide the foreign supplier's name and location and the products being imported. FDA Registration Assistance handles every step of the compliance process for both parties.
