Food Import Compliance Guide 2026: FDA, USDA & FSIS Requirements
- Overview: Who Regulates Food Imports?
- FDA Requirements: Prior Notice, Registration & FSMA
- USDA/FSIS Requirements: Meat, Poultry & Egg Products
- CBP Entry Process for Food Shipments
- Labeling Requirements: COOL, Nutrition Facts & Allergens
- Common Violations & How to Avoid Them
- Frequently Asked Questions
- Tools & Next Steps
Overview: Who Regulates Food Imports?
Importing food into the United States is one of the most heavily regulated categories in international trade. Unlike most merchandise imports — where CBP is the sole gatekeeper — food imports involve a layered system of federal agencies, each with jurisdiction over specific product categories and distinct legal authorities. Getting any one layer wrong can result in shipment holds, refusals, detentions, or destruction of cargo.
Three agencies govern the majority of food imports:
CBP (Customs and Border Protection) is the third layer — it controls the physical border and coordinates between FDA and FSIS. CBP officers at ports of entry can hold shipments pending agency review, issue holds based on import alert data, and refuse admission on behalf of either agency. If FDA or FSIS flags a shipment, CBP enforces the hold regardless of duty status.
USDA's Agricultural Marketing Service (AMS) also plays a role through country of origin labeling (COOL) requirements for specific commodities sold at retail.
The most common mistake food importers make is applying FDA rules to FSIS-regulated products or vice versa. A shipment of frozen chicken must enter through a USDA-designated port and requires FSIS inspection — FDA prior notice alone is not sufficient. Confirm which agency has jurisdiction over your specific product before filing any entry documentation.
FDA Requirements: Prior Notice, Registration & FSMA
FDA Prior Notice (21 CFR Part 1, Subpart I)
Prior notice is the single most operationally critical FDA requirement for food importers. Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (codified at 21 USC 331, 381), importers must notify FDA before food, animal feed, or dietary supplements arrive at any US port of entry. There is no grace period and no after-the-fact submission option — prior notice must be filed before arrival within the following windows:
| Mode of Transport | Minimum Filing Window | Maximum in Advance |
|---|---|---|
| Water (ocean/vessel) | 8 hours before arrival | 15 days |
| Air | 4 hours before arrival | 15 days |
| Land (from Mexico) | 4 hours before arrival | 15 days |
| Land (from Canada) | 2 hours before arrival | 15 days |
| Rail | 4 hours before arrival | 15 days |
Prior notice is submitted electronically through one of two systems: FDA's Prior Notice System Interface (PNSI) at access.fda.gov, or through the Automated Broker Interface (ABI) within ACE. Most licensed customs brokers file prior notice through ABI as part of the entry filing process. If you file through PNSI directly, retain the confirmation number — it must travel with the shipment and be presented to CBP upon arrival.
Under 21 USC 381(m), failure to submit adequate prior notice is grounds for refusal of admission. CBP will hold the shipment at the port, and the shipment cannot be released until FDA reviews the situation and makes a determination. This is not a fine — it is a refusal. The importer must pay storage costs during the hold, and FDA may order the food destroyed or re-exported at the importer's expense. Use our FDA Prior Notice Generator to prepare and review prior notice filings before submission.
Food Facility Registration (21 USC 350d)
Every foreign facility that manufactures, processes, packs, or holds food for US consumption must be registered with FDA under the Bioterrorism Act. This includes manufacturers, co-packers, cold storage facilities, and warehouse operations that handle food destined for the US market. Registration is done online at registration.fda.gov and must be renewed biennially during the October–December renewal window in even-numbered years.
As an importer, it is your responsibility to verify that your foreign suppliers are registered before you place orders. FDA can refuse entry of any food article from an unregistered foreign facility. This is not a matter of individual product safety — if the facility is unregistered, the food cannot enter regardless of whether it passes inspection. FDA publishes a searchable database of registered facilities. Check new suppliers before your first purchase order, not after the shipment arrives at the port.
FSMA Foreign Supplier Verification Program (FSVP)
The Food Safety Modernization Act (FSMA), signed into law in 2011, fundamentally shifted FDA's approach from reactive to preventive. The Foreign Supplier Verification Program (FSVP), codified at 21 CFR Part 1, Subpart L, requires importers to conduct risk-based verification activities to ensure their foreign suppliers are producing food in a manner that meets US safety standards.
FSVP applies to importers of human food and animal food. Key obligations include:
- Supplier evaluation: Conduct hazard analysis and evaluate the foreign supplier's performance and food safety practices before importation begins
- Verification activities: Annual onsite audits, product testing, review of supplier food safety records, or some combination based on risk level
- Corrective actions: Written procedures for addressing safety problems identified through verification activities
- Records: Maintain FSVP records for at least 2 years and present them to FDA on demand at the port of entry
- DUNS number: FSVP importers must provide their DUNS number in entry documentation, which FDA uses to identify the FSVP importer of record
Small and very small importers have modified FSVP requirements with longer phase-in periods. Dietary supplement importers have additional requirements under 21 CFR Part 111. Contact an FDA-registered food safety consultant to confirm your specific FSVP obligations based on product category and supplier risk level.
FSVP compliance and prior notice are both required for most FDA-regulated food imports — but they are completely separate obligations. Prior notice is a pre-arrival notification. FSVP is an ongoing supplier verification program. You need both. A valid prior notice filing does not indicate FSVP compliance, and FSVP records do not substitute for prior notice.
FDA Import Alerts and Detention Without Physical Examination (DWPE)
FDA maintains Import Alerts — publicly accessible notices that authorize CBP and FDA field offices to detain specific products or products from specific companies without conducting a physical examination. Import Alerts are issued when FDA has credible evidence of adulteration, misbranding, or serious safety concerns. The most severe Import Alerts result in Detention Without Physical Examination (DWPE), which means CBP can hold the shipment automatically upon arrival without waiting for a physical inspection to confirm the problem.
FDA Import Alerts are searchable at accessdata.fda.gov. Search by company name, country, or product category before purchasing from any new foreign supplier. An importer who fails to check Import Alerts before shipping carries significant risk — shipments from DWPE-listed suppliers can be detained at the port indefinitely, costing the importer storage fees while the situation is resolved.
USDA/FSIS Requirements: Meat, Poultry & Egg Products
USDA Food Safety and Inspection Service has mandatory inspection authority over a specific set of food categories. Unlike FDA, which primarily conducts risk-based random inspections, FSIS operates under a "100% inspection" model — every commercial shipment of an FSIS-regulated product must be physically inspected by a USDA inspector before it can be released into US commerce.
FSIS-Regulated Products
| Product Category | Regulation | Key Requirement |
|---|---|---|
| Meat products (beef, pork, lamb, goat — fresh, frozen, processed) | 9 CFR Part 327 | USDA-designated port of entry; equivalent country |
| Poultry products (chicken, turkey, duck — all forms) | 9 CFR Part 381 | USDA-designated port of entry; equivalent country |
| Egg products (liquid, frozen, dried) | 9 CFR Part 590 | Must come from shell eggs produced under equivalent inspection |
| Siluriformes fish (catfish) | 9 CFR Part 149 | FSIS equivalent country determination required |
The Equivalence Requirement
To import FSIS-regulated products into the United States, the exporting country's food safety system must be officially determined by FSIS to be "equivalent" to the US system under the Federal Meat Inspection Act and Poultry Products Inspection Act. This is not a product-by-product determination — it applies at the country and product category level. FSIS maintains a published list of eligible countries and the specific product categories approved for import from each country at fsis.usda.gov.
If your supplier's country does not appear on the FSIS eligible country list for your product category, importation is not possible regardless of the individual product's safety. There is no petition or exception process for individual importers — equivalence determinations are made between FSIS and the foreign government's food safety authority.
This is a hard stop. No broker relationship, no FDA waiver, no CBP workaround will allow FSIS-regulated products from a non-equivalent country into US commerce. Verify your supplier's country appears on the FSIS eligible country list — and that the specific product category is listed — before finalizing any purchase agreement.
USDA-Designated Ports of Entry
FSIS-regulated products can only be imported through ports of entry where USDA inspectors are permanently stationed. You cannot reroute an FSIS-regulated shipment to a non-USDA port because your normal freight lane runs there. FSIS publishes its list of import inspection facilities at fsis.usda.gov. Plan your logistics accordingly — if your foreign supplier ships to a port without USDA inspectors, the shipment cannot clear.
FSIS Import Reinspection Process
When an FSIS-regulated shipment arrives at a designated port, USDA inspectors conduct reinspection. This involves reviewing the official certificates issued by the foreign government's inspection authority, verifying that labels comply with USDA requirements, and conducting physical examination and sampling as warranted. A reinspection refusal means the shipment must be re-exported or destroyed under USDA supervision — at the importer's cost.
CBP Entry Process for Food Shipments
CBP serves as the logistical coordinator for food import inspections. Understanding how CBP's entry process intersects with FDA and FSIS is essential to avoiding holds and delays at the border.
Food Entry Filing in ACE
Food entries are filed in ACE (Automated Commercial Environment) like any other import. However, food entries trigger additional automated screening. ACE uses the Partner Government Agency (PGA) message set to route entry data to FDA and/or FSIS simultaneously with CBP review. When you or your broker files a food entry, the system automatically transmits the relevant product and shipment data to the appropriate regulating agency.
Key filing requirements for food entries include:
- Correct HTS classification: Misclassification of food products is a primary trigger for additional scrutiny. Use our Food & Beverage HTS Classification tool to confirm the correct subheading before filing
- Accurate country of origin: Country of origin for food products affects duty rates, COOL labeling requirements, and FSIS eligibility determinations
- FDA prior notice confirmation number: Must be included in the entry documentation if separately filed through PNSI
- FSVP DUNS number: Required for FSVP-subject importers in the PGA data
- Foreign facility registration number: The FDA-assigned registration number of the manufacturing facility
How CBP Decides to Inspect
CBP uses an automated targeting system (ATS) to assess risk on food shipments. ATS scores are based on factors including: the importer's compliance history, the exporting country's compliance record for that product category, the specific commodity, prior examination results for similar shipments, and active Import Alerts. A high ATS score triggers a "hold" — the shipment cannot be released until the designated agency conducts its review.
FDA has three examination options: document review only, physical examination at the port, or laboratory analysis of samples. Only a small percentage of FDA-regulated food shipments receive physical examinations — FDA operates on a risk-based sampling model given the volume of imports. FSIS, by contrast, inspects every regulated shipment.
CBP's targeting algorithm incorporates your supplier's history. A supplier who has had repeated FDA refusals or detention actions will raise your shipment's risk score even if the individual shipment is fully compliant. Screen new suppliers against FDA Import Alerts and FSIS eligibility lists using our Supplier Screening tool before placing orders.
What Happens When a Food Shipment is Held
When a food shipment is placed on hold by CBP, FDA, or FSIS, the sequence is as follows:
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Hold notice issued. CBP issues a hold message through ACE. The shipment cannot be removed from the port. Storage fees begin accruing immediately. The importer or broker receives a CBP Form 28 (request for information) or FDA/FSIS notice specifying the basis for the hold.
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Agency examination or documentation review. FDA or FSIS conducts the examination specified in the hold notice. This may take 1-5 business days for document review, or longer if physical examination and laboratory analysis are required. Laboratory analysis of microbiological or pesticide residue samples can take 2-4 weeks.
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Release or refusal decision. If the examination results are satisfactory, the agency issues a "May Proceed" status and CBP releases the shipment. If the examination identifies a violation, FDA issues a Notice of Refusal of Admission or FSIS issues a refusal of reinspection. At this point the importer has limited options.
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For FDA refusals: The importer may request reconditioning (relabeling, reprocessing) to bring the product into compliance, or the product must be re-exported or destroyed within 90 days. Reconditioning requires FDA approval and a supervision fee.
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For FSIS refusals: Products that fail FSIS reinspection must be re-exported under FSIS supervision or destroyed. No reconditioning option exists for most FSIS violations. All costs — shipping, storage, destruction — are borne by the importer.
Labeling Requirements: COOL, Nutrition Facts & Allergens
Food labeling compliance is enforced at the border. A product that fails FDA or USDA labeling requirements will be refused admission as "misbranded" under 21 USC 343 — regardless of whether the product itself is safe to eat. The most common labeling violations for imported food are misbranding, COOL violations, and allergen disclosure failures.
Country of Origin Labeling (COOL)
USDA's Agricultural Marketing Service (AMS) administers mandatory COOL requirements under the Agricultural Marketing Act (7 USC 1638 et seq.). The following commodities sold at retail must display country of origin:
- Fresh and frozen muscle cut and ground lamb, goat, and chicken
- Wild and farm-raised fish and shellfish
- Perishable agricultural commodities — fresh and frozen fruits and vegetables
- Peanuts, pecans, and macadamia nuts
Country of origin must appear on the retail package, or on a sign, label, or placard at the store shelf or bin for bulk items. For fish and shellfish, the label must also identify whether the product is wild-caught or farm-raised. Processed food items — those that have been physically or chemically altered from their covered commodity state (e.g., marinated, smoked, or combined with other ingredients) — are generally exempt from COOL. Penalties for COOL violations can reach $10,000 per violation under 7 USC 1638d.
FDA Nutrition Labeling
Imported food products intended for retail sale must comply with FDA's updated Nutrition Facts label requirements under 21 CFR Part 101. Key requirements include: a Nutrition Facts panel in the correct format, serving size declarations consistent with FDA's Reference Amounts Customarily Consumed (RACC), and updated daily values for nutrients. Products manufactured before January 1, 2020 may still carry the old format in some circumstances, but most manufacturers have now transitioned to the new format. Imported products with non-compliant labels will be refused as misbranded.
Food Allergen Labeling
The Food Allergen Labeling and Consumer Protection Act (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act require declaration of the following major food allergens on any food label: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, and sesame. Allergens must be declared either in the ingredient list or in a "Contains:" statement immediately following the ingredients. A foreign product that uses only ingredient names (without English allergen declarations) will be refused as misbranded under 21 USC 343(x).
FDA requires that all required label information on food offered for retail sale in the United States be in English (21 CFR 101.15). Foreign-language labels may be used in addition to, but not instead of, English-language required declarations. A product imported with only a foreign-language label will be held as misbranded unless the importer can demonstrate it is not intended for retail sale in the US (e.g., food service or institutional use with proper documentation).
USDA FSIS Labeling for Meat and Poultry
FSIS requires that imported meat and poultry products carry labels that comply with FSIS regulations (9 CFR Part 317 for meat, 9 CFR Part 381 Subpart N for poultry). All FSIS-regulated labels must be pre-approved by FSIS before use — the label approval number must be on file. Labels must include: product name, ingredients in descending order of predominance by weight, net weight, name and address of the US importer or distributor, safe handling instructions, and the FSIS inspection legend with the establishment number of the foreign plant. Products arriving with unapproved or non-compliant FSIS labels will be refused reinspection.
Common Violations and How to Avoid Them
Most food import compliance failures fall into a predictable set of categories. Understanding the most common violations — and what causes them — is the most efficient way to protect your import program.
Before any food shipment departs the country of origin, confirm:
- FDA prior notice filing window is scheduled (do not wait until arrival)
- Foreign facility registration number verified and active at registration.fda.gov
- Supplier not listed on any active FDA Import Alert at accessdata.fda.gov
- For FSIS products: country on eligible country list, port is USDA-designated
- English-language labels with compliant Nutrition Facts and allergen declarations
- COOL disclosures correct for covered commodities
- FSVP documentation current and on file for FDA-regulated products
Use our Import Compliance Checker to run a pre-shipment review against FDA and FSIS requirements for your specific product category and supplier country.
Frequently Asked Questions
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- 21 CFR Part 1, Subpart I — FDA Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- 21 USC 350d — Registration of food facilities (Bioterrorism Act)
- 21 USC 381 — Imports and exports; refusal of admission
- 21 CFR Part 1, Subpart L — Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- 9 CFR Part 327 — Imported Meat and Meat Products (FSIS)
- 9 CFR Part 381, Subpart T — Imported Poultry Products (FSIS)
- 9 CFR Part 590 — Inspection of Eggs and Egg Products (FSIS)
- 7 USC 1638 et seq. — Country of Origin Labeling (COOL), Agricultural Marketing Act
- FDA Import Alerts — accessdata.fda.gov
- USDA FSIS Import Requirements — fsis.usda.gov
- FDA Food Facility Registration — registration.fda.gov
- 21 CFR Part 101 — Food Labeling (FDA Nutrition Facts requirements)
- Public Law 108-282 (FALCPA) and Public Law 117-11 (FASTER Act) — Major Food Allergen Labeling