Importing food into the United States is an FDA compliance project layered on top of a customs entry. Before a commercial food shipment can enter the country, the foreign facility generally needs FDA Food Facility Registration, a U.S. Agent, and the U.S. importer needs to meet Foreign Supplier Verification Program (FSVP) requirements. Every shipment also requires Prior Notice before arrival.
There is an important deadline in 2026. FDA Food Facility Registration must be renewed between October 1 and December 31, 2026. The renewal applies to registered facilities during every even-numbered year. Missing the deadline can result in cancellation of the registration and prevent food shipments from entering the United States until the facility is properly registered again.
FDA compliance is only one part of the process. Customs classification, duty, tariffs, country of origin, CBP entry filing, and, for certain products, USDA or TTB requirements must also be addressed.
This guide explains the complete process for commercial food and beverage imports, from determining which agency regulates your product through FDA compliance, customs clearance, tariffs, and common detention problems.
Which Agency Regulates Your Food: FDA, USDA, or TTB
Most imported food and beverages fall under FDA jurisdiction, but meat, poultry, processed egg products, and alcoholic beverages can involve additional federal agencies.
FDA: Most Food and Beverages
The U.S. Food and Drug Administration (FDA) regulates most foods and beverages imported into the United States. This includes products such as:
- Fruits and vegetables
- Coffee and tea
- Cereals and grains
- Confectionery
- Snack foods
- Sauces and condiments
- Seafood
- Bottled water
- Non-alcoholic beverages
- Processed foods
- Dietary supplements
The FDA Center for Food Safety and Applied Nutrition (CFSAN) administers many of the food safety and labeling requirements.
USDA FSIS: Meat, Poultry, and Processed Eggs
The U.S. Department of Agriculture (USDA) and its Food Safety and Inspection Service (FSIS) regulate meat, poultry, and certain processed egg products.
These products have requirements that differ from standard FDA food imports. The exporting country must generally be eligible to export the relevant product to the United States, and the producing establishment may also need to be eligible.
Imported meat and poultry are subject to FSIS inspection requirements under regulations including 9 CFR Part 327 for meat and 9 CFR Part 381 for poultry.
TTB: Alcoholic Beverages
Alcoholic beverages can involve the Alcohol and Tobacco Tax and Trade Bureau (TTB) in addition to FDA and CBP requirements.
Importers of beer, wine, and distilled spirits may need the appropriate TTB permit, comply with labeling requirements, and account for federal excise tax.
How to Determine Which Applies to Your Product
Start with the product itself, not the name used for marketing it. Ingredients, processing method, intended use, alcohol content, and whether the product contains meat or poultry can determine which agency has jurisdiction.
Some products can involve multiple agencies. For example, an alcoholic beverage may require TTB compliance while also being subject to FDA requirements and CBP customs entry requirements.
Once the regulatory agency is established, the next step for most food imports is the FDA framework.
The FDA Framework Under FSMA
The Food Safety Modernization Act shifted U.S. food regulation toward prevention, requiring businesses throughout the supply chain to identify and control food safety risks.
What FSMA Changed
The Food Safety Modernization Act (FSMA) was signed into law in 2011 and expanded the FDA’s preventive approach to food safety.
Rather than focusing only on what happens after contaminated food reaches consumers, FSMA established requirements intended to identify hazards and prevent them before food enters commerce.
For importers, this created significant obligations involving foreign suppliers and verification of their food safety practices.
The Bioterrorism Act Foundation
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, commonly called the Bioterrorism Act, established important food import controls before FSMA.
It introduced requirements including food facility registration and Prior Notice of imported food shipments.
FSMA subsequently added a broader preventive compliance framework.
The Two Distinct Parties: Foreign Facility and U.S. Importer
One of the most important concepts for a first-time food importer is that the foreign facility and U.S. importer have different responsibilities.
The foreign facility generally handles:
- FDA Food Facility Registration
- Designation of a U.S. Agent
- Compliance with applicable food safety requirements
- Providing information needed for FDA filings
The U.S. importer or FSVP importer generally handles:
- Foreign Supplier Verification Program compliance
- Supplier verification
- Hazard evaluation
- Corrective actions
- FSVP records
- Import-related information
These responsibilities can overlap operationally, but registering a foreign facility does not make the facility FSVP-compliant.
Which Obligations Fall on Whom
A foreign manufacturer cannot simply tell a U.S. distributor that “the FDA registration is done” and assume all requirements have been satisfied.
Similarly, a U.S. importer cannot assume that its supplier’s FDA registration means the importer has met its FSVP obligations.
The two sides need to coordinate before the first shipment.
Food Facility Registration and the 2026 Biennial Renewal
FDA Food Facility Registration is generally required for facilities that manufacture, process, pack, or hold food for consumption in the United States.
Who Must Register
Foreign and domestic facilities covered by FDA’s registration requirements generally must register before operating within the applicable food supply chain.
The requirement can apply to manufacturers, processors, packers, and facilities that hold food.
A registration is associated with the facility and provides FDA with information about the business and its operations.
The FDA Registration Number
Once registered, the facility receives an FDA registration number.
This number should be kept with the facility’s compliance records and supplied when required for import transactions.
An FDA registration number is not the same thing as an approval or certification that FDA has reviewed and approved every product manufactured at the facility.
The Biennial Renewal Window: October to December 2026
FDA Food Facility Registration must be renewed during the October 1 through December 31, 2026 biennial renewal window.
Renewal occurs every even-numbered year.
Facilities should review their registration information before submitting the renewal. Changes to ownership, address, facility activities, or other registration information may require updates rather than simply confirming the existing information.
What Happens If You Miss the Renewal
Missing the biennial renewal can result in cancellation of the food facility registration.
A facility whose registration has been cancelled may encounter serious problems when its products are presented for import.
Re-registration should be completed before future shipments are sent. Waiting until cargo is already moving can create avoidable delays.
For foreign suppliers shipping regularly to the United States, the 2026 renewal should therefore be treated as a calendar deadline, not an administrative task to address after the fact.
Low-Acid Canned Foods and Additional Registration
Low-acid canned foods and certain acidified foods have additional FDA requirements.
Facilities producing applicable products may need Food Canning Establishment (FCE) registration and must file a Scheduled Process (SID) for applicable products.
These requirements are separate from ordinary Food Facility Registration.
The U.S. Agent Requirement for Foreign Facilities
A foreign food facility generally must designate a U.S. Agent who serves as FDA’s point of contact in the United States.
Why Foreign Facilities Need a U.S. Agent
FDA needs a U.S.-based contact for communications with foreign facilities.
The U.S. Agent must be located in the United States and is designated by the foreign facility during registration.
What the U.S. Agent Does
The U.S. Agent can receive FDA communications on behalf of the foreign facility and help facilitate communication regarding regulatory matters.
Foreign facilities should choose an agent that understands the responsibility rather than treating the role as a simple name-and-address requirement.
How the U.S. Agent Differs From the Importer of Record
The U.S. Agent is not automatically the importer of record.
The importer of record is responsible for customs entry obligations, including ensuring that the entry is properly classified, valued, documented, and that applicable duties and fees are paid.
The FSVP importer is a separate concept again. Depending on the transaction, the FSVP importer can be the U.S. owner or consignee or another qualifying U.S. party.
Foreign Supplier Verification Program (FSVP)
Under the Foreign Supplier Verification Program, the U.S. importer is responsible for verifying that foreign suppliers produce food in compliance with applicable U.S. food safety requirements.
Who Is the FSVP Importer?
The FSVP importer is generally the U.S. owner or consignee of the food at the time of entry.
If there is no U.S. owner or consignee, the applicable foreign owner or consignee may need to designate a U.S. agent or representative who accepts responsibility for FSVP purposes.
The FSVP importer must be identified appropriately for FDA entry purposes.
The Unique Facility Identifier Requirement
FSVP importers need a Unique Facility Identifier (UFI) recognized by FDA. A DUNS number is commonly used for this purpose.
The FSVP importer’s information needs to be accurate and consistent with the customs and FDA entry information.
Supplier Verification Obligations
An FSVP generally involves evaluating the foreign supplier and identifying known or reasonably foreseeable hazards associated with the food.
Depending on the risk and circumstances, verification activities can include:
- Supplier food safety records
- Sampling and testing
- Supplier audits
- Food safety certifications
- Corrective action records
- Review of supplier compliance history
The appropriate verification method depends on the food, hazards, supplier, and applicable regulations.
Records and Two-Year Retention
FSVP records generally must be retained for at least two years.
Records should be organized so that the importer can demonstrate how it evaluated and verified the supplier.
FSVP Inspections
FDA can inspect FSVP records as part of its regulatory activities.
An importer that cannot produce required records can face compliance problems even when the foreign supplier itself has an otherwise acceptable food safety program.
Exemptions
Not every food transaction is subject to FSVP in exactly the same way.
Certain products, suppliers, and situations have exemptions or modified requirements. USDA-regulated products, for example, fall outside the ordinary FSVP framework when they are subject to the applicable FSIS requirements.
The importer should determine the specific regulatory status of the product before relying on an exemption.
Prior Notice for Every Shipment
Every food shipment imported into the United States generally requires electronic Prior Notice before arrival.
What Prior Notice Is
Prior Notice gives FDA information about an incoming food shipment before it reaches the United States.
It allows FDA to identify and assess food shipments before arrival.
How and When to File
Prior Notice can generally be transmitted through FDA’s Prior Notice System Interface (PNSI) or through the customs entry process using ABI/ACE.
The filing requires information about the product, manufacturer, shipper, consignee, carrier, country of origin, and other shipment details.
Timing by Mode of Transport
The deadline depends on how the shipment arrives.
Air and vessel shipments generally require Prior Notice at least four hours before arrival. Rail and road shipments generally require it at least two hours before arrival.
Different rules apply to international mail and courier shipments.
The filing should be completed with enough time to correct errors before arrival.
Why Missing Prior Notice Is a Common Detention Reason
Incorrect or missing Prior Notice can result in the shipment being held.
Common problems include incorrect manufacturer information, mismatched product descriptions, incorrect facility registration information, and discrepancies between the FDA filing and customs entry.
FSMA Preventive Controls and Food Safety Plans
The Preventive Controls for Human Food rule requires covered facilities to identify food safety hazards and establish controls to prevent or significantly minimize those hazards.
The Preventive Controls for Human Food Rule
The requirements are established primarily under 21 CFR Part 117.
Covered facilities generally need a food safety plan based on a hazard analysis and preventive controls.
Hazard Analysis and the Food Safety Plan
The facility evaluates biological, chemical, and physical hazards that could affect the food.
The resulting food safety plan establishes preventive controls and procedures for monitoring and corrective action.
The Qualified Individual Requirement
A qualified individual must oversee or perform certain food safety activities.
The individual needs the education, training, or experience required for the applicable responsibilities.
How Preventive Controls Relate to FSVP
Preventive controls apply primarily to the covered facility and its food safety system.
FSVP applies to the U.S. importer and its verification of foreign suppliers.
They address different responsibilities but work together. The importer should be able to demonstrate that it has evaluated the supplier’s food safety practices rather than simply relying on the supplier’s registration number.
HTSUS Classification for Food and Beverages
FDA admissibility and customs classification are separate questions. A product can satisfy FDA requirements and still be incorrectly entered with CBP.
Food and beverages are classified under the Harmonized Tariff Schedule of the United States (HTSUS).
Animal Products: Chapters 1-5
Chapters 1 through 5 cover many animal-origin products, including meat, fish, dairy-related products, and other animal products.
The exact classification depends on the product’s composition, processing, packaging, and intended use.
Vegetable Products: Chapters 6-14
Vegetables, fruits, grains, nuts, seeds, and related products are generally found across Chapters 6 through 14.
A processed food may move to a different chapter depending on how it is prepared.
Prepared Foods and Beverages: Chapters 16-24
Prepared food products are commonly found in Chapters 16 through 21, while beverages and related products are generally found in Chapters 22 and 23.
Chapter 24 covers tobacco and manufactured tobacco substitutes.
Common Beverage and Specialty Food Classifications
Some frequently encountered headings include:
- 0901: Coffee
- 0902: Tea
- 1806: Chocolate and food preparations containing cocoa
- 2009: Fruit and vegetable juices
- 2106: Food preparations not elsewhere specified
- 2202: Non-alcoholic beverages and certain other beverages
These headings are starting points, not automatic classifications. The actual HTSUS number depends on the product.
Why Classification Affects Duty and Admissibility
HTSUS classification determines the applicable duty rate and can also affect quota requirements, additional tariffs, trade remedies, and agency requirements.
For food, classification can also interact with USDA, FDA, and country-of-origin requirements.
Duty and Tariff Treatment for Imported Food
The duty on imported food depends on the HTSUS classification, country of origin, trade program eligibility, and any additional tariffs or quotas that apply.
MFN Duty Rates by Category
Most imports receive the applicable general or Most-Favoured-Nation (MFN) rate under the HTSUS.
Food duty rates range widely. Some products enter duty-free, while others have rates exceeding 20%.
Tariff Rate Quotas for Sensitive Products
Certain agricultural products are subject to Tariff Rate Quotas (TRQs).
A specified quantity may enter at a lower tariff rate, while imports above the quota can face substantially higher rates.
Sugar and certain dairy and agricultural products are examples where quota treatment can materially affect landed cost.
Section 301 Exposure on Chinese-Origin Food
Chinese-origin food products can be subject to additional Section 301 tariffs, depending on their classification and the applicable tariff measures.
Importers should not assume that food is exempt simply because it is an agricultural or consumer product.
USMCA Eligibility
Products originating in Canada or Mexico may qualify for preferential treatment under the United States-Mexico-Canada Agreement (USMCA) when they satisfy the applicable rules of origin.
Origin is determined by the applicable trade rules, not simply by the country from which the goods were shipped.
A Worked Landed Cost Example
Suppose an importer brings $20,000 of food from a country subject to a 10% MFN duty rate.
The base duty would be:
$20,000 × 10% = $2,000
If an additional tariff applies, that must be calculated separately. The importer must also account for the Merchandise Processing Fee (MPF) and, for applicable ocean shipments, the Harbor Maintenance Fee.
FDA compliance costs, customs brokerage, freight, insurance, storage, and other charges can then be added to determine the actual landed cost.
The USDA and FSIS Layer for Meat, Poultry, and Eggs
Meat, poultry, and certain processed egg products are regulated by USDA FSIS rather than the ordinary FDA food import framework.
What FSIS Regulates
FSIS regulates covered meat, poultry, and processed egg products.
This includes imported products that might otherwise appear to be ordinary food imports but have specific USDA jurisdiction.
Country and Establishment Eligibility
The exporting country must generally be eligible to export the relevant product to the United States.
The establishment producing the product may also need to be eligible under FSIS requirements.
FSIS Import Inspection
Imported products subject to FSIS jurisdiction are presented for inspection.
The importer must ensure that the shipment is properly documented and routed through the applicable inspection process.
The FDA-FSIS Jurisdiction Split
The distinction matters because an importer cannot simply apply FDA registration and Prior Notice procedures to every food product.
For a meat or poultry product, the importer needs to establish the applicable FSIS requirements before shipment.
The CBP Customs Clearance Process and PREDICT Screening
FDA compliance and customs clearance converge when the shipment reaches the U.S. port, but CBP and FDA make different decisions about the shipment.
Entry Documentation
A commercial food shipment generally requires documentation including:
- Commercial invoice
- Packing information
- Bill of lading or airway bill
- HTSUS classification
- Country of origin
- Customs value
- FDA product information
- Prior Notice information
- Other permits or agency documents where applicable
The entry is filed through the Automated Commercial Environment (ACE).
How Prior Notice Links to the Customs Entry in ACE
FDA data is transmitted as part of the import process and must correspond with the physical shipment and customs entry.
Discrepancies can create holds or requests for additional information.
PREDICT Risk Screening
FDA uses PREDICT, a risk-based screening system, to assess imported products.
The system can evaluate information associated with the product, manufacturer, importer, country, previous compliance history, and other risk factors.
A shipment receiving a “May Proceed” message has cleared the relevant automated screening stage. That does not necessarily mean every regulatory obligation has ended.
May Proceed, Hold, and Detention Outcomes
FDA may allow a shipment to proceed, request additional information, or detain the shipment.
A detention can occur without a physical examination under Detention Without Physical Examination (DWPE) when an applicable FDA Import Alert or other regulatory basis exists.
Specific Product Categories and Their Requirements
Food category matters because specialized products can carry requirements beyond ordinary FDA food import compliance.
Seafood: Seafood HACCP
Seafood imports are subject to the Seafood HACCP requirements under 21 CFR Part 123.
Importers and foreign processors need to address hazards associated with the seafood and ensure the applicable preventive controls are documented.
Juice: Juice HACCP
Juice processors are subject to Juice HACCP requirements under 21 CFR Part 120.
The importer should verify that the foreign supplier’s controls satisfy the applicable requirements before shipment.
Low-Acid Canned and Acidified Foods
Low-acid canned foods are subject to requirements under 21 CFR Part 113, including applicable FCE registration and SID filings.
Acidified foods can have similar additional requirements.
Dietary Supplements
Dietary supplements are regulated by FDA but are subject to requirements that differ from conventional foods.
The importer needs to consider ingredient safety, labeling, manufacturing requirements, and applicable facility obligations.
Coffee, Tea, and Confectionery
Coffee, tea, chocolate, candy, and snack products commonly fall within FDA jurisdiction.
Their customs classification can vary significantly based on ingredients and processing. A chocolate confectionery product, for example, should not be classified simply because its marketing description says “chocolate.”
Bottled Water and Beverages
Bottled water and non-alcoholic beverages are generally FDA-regulated.
The formulation, packaging, labeling, and applicable standards of identity can affect compliance.
Alcoholic Beverages: TTB
Alcoholic beverages can require TTB permits and compliance in addition to FDA and CBP requirements.
Importers should establish TTB requirements before placing an order because federal alcohol requirements can affect both licensing and labeling.
Common Detention Reasons and How to Avoid Them
Most food import problems can be reduced by completing FDA and customs requirements before the shipment leaves the foreign facility.
Prior Notice Errors
Incorrect Prior Notice information can cause a shipment to be held.
Check the manufacturer, product, quantity, consignee, country of origin, and facility information against the actual shipment.
Unregistered Facility
If a foreign facility that is required to register has no valid registration, the shipment can encounter problems at entry.
The 2026 biennial renewal makes this especially important for shipments arriving late in the year.
FSVP Non-Compliance
An importer that cannot produce required FSVP records can face FDA action.
The importer should maintain supplier verification documentation rather than attempting to create an FSVP after a shipment has already been selected for review.
Labeling Violations
Food labels must comply with applicable FDA requirements.
Common issues can involve ingredient declarations, allergen information, nutrition labeling, net quantity, identity statements, and other labeling requirements.
Contamination and Adulteration
FDA can take action where products are adulterated, contaminated, contain prohibited substances, or present food safety risks.
Pesticide tolerances administered by the Environmental Protection Agency (EPA) can also affect imported food.
Active Import Alerts and DWPE
An FDA Import Alert can result in products being subject to Detention Without Physical Examination (DWPE).
Importers should check whether their product, supplier, or country is affected by an applicable alert before shipping.
Frequently Asked Questions About Importing Food into the U.S.
1. Do I need FDA registration to import food into the U.S.?
Generally, the foreign facility that manufactures, processes, packs, or holds covered food must be registered with FDA. Registration is separate from FSVP, Prior Notice, customs entry, and product-specific requirements.
2. When is the 2026 FDA food facility registration renewal deadline?
The 2026 biennial renewal window runs from October 1 through December 31, 2026. Facilities that fail to renew during the applicable window can have their registration cancelled.
3. What is the difference between facility registration and FSVP?
Facility registration identifies a facility with FDA. FSVP is an importer responsibility requiring verification that foreign suppliers meet applicable U.S. food safety requirements. Completing one does not satisfy the other.
4. Who needs to file Prior Notice, and when?
Prior Notice is required for covered food shipments before they arrive in the United States. It can be filed through FDA’s Prior Notice system or through the customs entry process. Timing depends on the transportation method.
5. Do foreign food facilities need a U.S. Agent?
Generally, yes. Foreign facilities subject to FDA Food Facility Registration requirements must designate a U.S. Agent who can act as FDA’s point of contact in the United States.
6. What is FSVP and who is the FSVP importer?
The Foreign Supplier Verification Program requires the applicable U.S. importer to verify its foreign suppliers. The FSVP importer is generally the U.S. owner or consignee, subject to the specific rules applicable to the transaction.
7. Which foods are regulated by USDA instead of FDA?
Meat, poultry, and certain processed egg products are regulated by USDA FSIS. Alcoholic beverages can also involve TTB jurisdiction in addition to FDA and CBP.
8. What HTSUS chapter does food fall under?
Food can fall across HTSUS Chapters 1 through 24 depending on its ingredients, processing, and composition. Coffee is commonly in heading 0901, tea in 0902, chocolate in 1806, juices in 2009, and certain food preparations in 2106.
9. What duty applies to imported food?
Duty depends on the product’s HTSUS classification, country of origin, trade program eligibility, quotas, and additional tariffs. There is no single duty rate for all imported food.
10. Do Chinese-origin food imports face Section 301 tariffs?
Some Chinese-origin food products can be subject to Section 301 tariffs in addition to their ordinary duty. The exact treatment depends on the HTSUS classification and current tariff measures.
11. What are the most common reasons food is detained at the border?
Common issues include missing or incorrect Prior Notice, an unregistered facility, FSVP problems, labeling violations, adulteration, contamination, pesticide issues, and products covered by FDA Import Alerts.
12. Do I need FDA compliance to sell imported food on Amazon?
Yes. Selling through Amazon does not remove FDA or customs obligations. The importer remains responsible for meeting applicable requirements before the food enters U.S. commerce.
13. What happens if my food facility registration expires?
A cancelled registration can prevent shipments associated with the facility from entering normally. The facility should complete the applicable re-registration process before shipping additional products.
14. Do seafood imports have special requirements?
Yes. Seafood is subject to Seafood HACCP requirements under 21 CFR Part 123. Importers should verify supplier compliance and maintain the applicable documentation.
15. Do I need a customs broker to import food?
A customs broker is not universally mandatory for every import transaction, but commercial food imports involve both customs and FDA requirements that can be difficult to manage independently. A broker can coordinate classification, entry filing, agency data, duties, and clearance.
16. How does the post-Section 321 environment affect food e-commerce?
Food sold through e-commerce still has to meet applicable FDA requirements even when individual shipments might otherwise qualify for low-value customs treatment. Importers should not assume that a low-value shipment avoids FDA requirements. Understanding Section 321 is important.
Bringing It Together
Importing food into the United States requires coordination between FDA compliance and customs clearance. The foreign facility and U.S. importer have different responsibilities, and those responsibilities should be established before the first shipment moves.
For most food products, the basic workflow is:
- Determine whether FDA, USDA FSIS, TTB, or multiple agencies regulate the product.
- Confirm the foreign facility’s FDA registration where required.
- Check the October 1 to December 31, 2026 biennial renewal requirement.
- Confirm the foreign facility has a U.S. Agent.
- Identify the FSVP importer and complete the supplier verification process.
- Determine the correct HTSUS classification.
- Calculate applicable duty, tariffs, quotas, MPF, and other charges.
- File accurate Prior Notice.
- Prepare the customs entry through ACE.
- Monitor FDA and CBP release decisions.
- Maintain the records supporting the import transaction.
The key is to treat FDA compliance and customs as two parts of the same import transaction. A shipment can have the correct customs classification and still be stopped because of an FDA issue. It can also satisfy FDA requirements even if the HTSUS classification or duty calculation is incorrect.
For food brands, distributors, and foreign manufacturers entering the U.S. market, completing these requirements before the cargo moves is usually far easier than resolving a compliance problem after the shipment reaches the port.
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