FDA Import Requirements: What Every Food and Beverage Importer Must Know

Who actually regulates your shipment

Most packaged foods and beverages fall under the U.S. Food and Drug Administration. USDA handles meat, poultry, and processed egg products. Alcoholic beverages are shared with TTB and sometimes FDA. If you are not sure, ask us to map your SKU list to the right agency before you book cargo. For FDA-regulated foods, everything below applies.

1. Food Facility Registration, and the U.S. Agent requirement

Any facility that manufactures, processes, packs, or holds food for U.S. consumption must register with FDA. Registration must be renewed every even-numbered year between October 1 and December 31. FDA requires a Unique Facility Identifier. FDA currently recognizes the D-U-N-S number as the acceptable UFI. If registration is not renewed by December 31 of the renewal year, the registration is considered expired. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2

2. Prior Notice before shipment arrives

FDA must receive an electronic Prior Notice for each FDA food entry. Timing depends on mode of transport, but the key is that Prior Notice must be on file before the food arrives, so FDA and CBP can target and protect the food supply. U.S. Food and Drug Administration+1

3. FSVP, the Foreign Supplier Verification Program

Importers must verify that each foreign supplier produces food that meets U.S. safety standards and is not adulterated or misbranded for allergens. This is not a paper form. It is an actual, living program with hazard analyses, supplier evaluations, verification activities, and recordkeeping. At entry, you identify the FSVP importer in ACE. U.S. Food and Drug Administration+1

4. Special process rules for certain foods

Seafood requires Seafood HACCP importer verification. Juice requires Juice HACCP with specific importer duties. Low-acid and acidified canned foods require establishment registration and process filing with FDA forms 2541 series. These rules apply in addition to FSVP, or in some cases provide specific exemptions from parts of FSVP, but importers still have entry-time obligations. U.S. Food and Drug Administration+3U.S. Food and Drug Administration+3eCFR+3

5. Traceability records for listed foods

FDA issued the Food Traceability Rule under FSMA. FDA has proposed to extend the compliance date by 30 months to July 20, 2028. Plan now, but note the new date is proposed, not yet final. U.S. Food and Drug Administration+1

Role clarity at entry: Importer of Record, FSVP Importer, and consignee

• Importer of Record pays duties and is responsible for CBP entry.
• FSVP Importer is the U.S. party that develops and maintains the verification program and is declared to FDA at entry.
• The same company can be both, but does not have to be. Getting this wrong creates holds and 72-hour document scrambles. U.S. Food and Drug Administration

Step-by-step: your FDA import playbook

Step 1. Validate facility registration and UFI

• Confirm each foreign manufacturer, packer, and holder has an active FDA Food Facility Registration with a valid D-U-N-S number as its UFI.
• Check upcoming biennial renewal windows and make sure the U.S. Agent is accurate. We can pre-check this before you place a purchase order. U.S. Food and Drug Administration+1

Step 2. Build or update your FSVP

For each SKU and supplier, keep the following on file and current:

• Hazard analysis for the food.
• Supplier evaluation and approval decision.
• Verification activities, for example audits, sampling and testing with specifications, and document reviews.
• Corrective actions when something goes wrong.
• Qualified individual credentials.
• Clear identification of the FSVP importer name, email, and DUNS that will be transmitted at entry. U.S. Food and Drug Administration

Common exemptions or modified FSVP options exist, for example when you are subject to Seafood HACCP or Juice HACCP, or when importing for research or evaluation. Know the scope of any exemption and what you still must file at entry. U.S. Food and Drug Administration

Step 3. File accurate Prior Notice

• Ensure product descriptions match labels and invoices.
• Provide packaging sizes, manufacturer, anticipated arrival, and carrier details.
• The Prior Notice confirmation number should be linked to the entry. Errors create avoidable FDA holds. U.S. Food and Drug Administration

Step 4. Meet any special process rules

Seafood HACCP
Importers must have written verification procedures and take an affirmative step to ensure foreign processors comply with 21 CFR 123. Examples include obtaining HACCP and sanitation monitoring records or conducting onsite audits. Expect FDA to inspect importers for these duties. U.S. Food and Drug Administration

Juice HACCP
Under 21 CFR 120.14, importers must provide evidence that imported juice was processed under conditions that comply with Part 120 or from a country with an appropriate MOU. Absent adequate assurances, the product appears adulterated and will be denied entry. eCFR

Low-acid canned foods and acidified foods
Foreign processors must register and file scheduled processes on FDA Form 2541 series before offering product for U.S. import. FDA may refuse admission until the processor demonstrates compliance. U.S. Food and Drug Administration+1

Step 5. Prepare for traceability if your foods are on the list

Create a traceability plan, capture Key Data Elements at Critical Tracking Events, and validate that your suppliers can transmit the data you need. Track the proposed new compliance date of July 20, 2028. U.S. Food and Drug Administration+1

Import Alerts, DWPE, and refusals

FDA uses Import Alerts to detain shipments without physical examination when patterns of non-compliance exist. Red List means your goods or firm are subject to DWPE. Green List means exempt from DWPE under that alert. If your supplier refused an FDA foreign inspection, Import Alert 99-32 can place them on DWPE until they petition for inspection and FDA returns. A refused entry must be exported or destroyed under supervision. We monitor these lists for you before you book cargo. U.S. Food and Drug Administration+3U.S. Food and Drug Administration+3FDA Access Data+3

Labeling and allergen basics that trip up imports

Labels must meet FDA requirements, including statement of identity, net quantity, ingredient list in descending order, allergen labeling under FALCPA for major allergens, and a compliant Nutrition Facts panel where required.

Country of origin marking is a CBP rule that still applies in retail.

FSVP specifically calls out misbranding with respect to allergen labeling as a core risk to control. We review proofs before printing to reduce holds. U.S. Food and Drug Administration

Entry documentation checklist for your broker and your files

• FDA product code, intended use code, and accurate manufacturer information.
• Prior Notice confirmation. U.S. Food and Drug Administration
• Facility registration numbers and UFI confirmation for relevant parties. U.S. Food and Drug Administration
• FSVP Importer name and D-U-N-S as required in ACE. U.S. Food and Drug Administration
• If applicable: Seafood HACCP importer verification records. U.S. Food and Drug Administration
• If applicable: Juice HACCP evidence under 21 CFR 120.14. eCFR
• If applicable: LACF or acidified food scheduled process filings. U.S. Food and Drug Administration

The most common mistakes we see, and how to avoid them

• Expired or never-renewed Food Facility Registration for a co-packer or warehouse. Solution, verify status and UFI for all parties at quoting stage, not at arrival. U.S. Food and Drug Administration
• Using the wrong party as FSVP importer which triggers document requests to a company that has no program. Solution, decide the FSVP importer per SKU and supplier and transmit that data consistently. U.S. Food and Drug Administration
• Missing Juice or Seafood HACCP importer records. Solution, maintain written procedures and affirmative steps ready for inspection. U.S. Food and Drug Administration+1
• No process filing for acidified or low-acid canned foods. Solution, complete Form 2541 filings and keep the submissions in your technical file before the first shipment. U.S. Food and Drug Administration
• Assuming traceability can wait until the deadline. Solution, start data capture pilots now while FDA’s proposed extension to July 20, 2028 moves through rulemaking. U.S. Food and Drug Administration
• Ignoring Import Alerts until a load is detained. Solution, pre-screen suppliers and lots against current alerts and verify removal steps if a factory is on a Red List. U.S. Food and Drug Administration

VQIP, the fast lane for proven importers

The Voluntary Qualified Importer Program is a fee-based program that expedites review and import entry for participating importers with strong safety systems. Benefits include fewer examinations and faster release. Eligibility requires, among other things, a Quality Assurance Program that covers all imported foods and suppliers, plus a history of compliance. U.S. Food and Drug Administration+1

A simple readiness self-assessment

Answer “yes” to all before you buy.

• We validated registration and D-U-N-S for every involved facility. U.S. Food and Drug Administration
• We have an FSVP for each supplier and SKU, with documented hazard analyses, verification, and records. U.S. Food and Drug Administration
• We know who the FSVP importer is for each line and that name will be transmitted in ACE. U.S. Food and Drug Administration
• Prior Notice data will be filed correctly and on time. U.S. Food and Drug Administration
• Seafood, juice, and LACF products meet the extra rules and paperwork. U.S. Food and Drug Administration+2eCFR+2
• We checked current Import Alerts for our factories and commodities. U.S. Food and Drug Administration
• If our foods are on the traceability list, we have a plan and system build under way. U.S. Food and Drug Administration

How Stile Associates helps you stay compliant without slowing down cargo

• Pre-entry FDA screening of suppliers, registration status, UFI, and Import Alerts.
• FSVP build-out and maintenance with practical templates and supplier coaching. U.S. Food and Drug Administration
• Label and document review aligned to Prior Notice and ACE data. U.S. Food and Drug Administration
• Special rule navigation for Seafood HACCP, Juice HACCP, and LACF filings. U.S. Food and Drug Administration+2eCFR+2
• Traceability roadmap that starts with today’s vendors and systems, then scales to full FSMA 204 compliance on time. U.S. Food and Drug Administration
• VQIP preparation if you want the fastest lane available for compliant importers. U.S. Food and Drug Administration

FAQ

Do small quantities or samples need Prior Notice
Yes, unless a specific exemption applies such as certain research or evaluation imports. U.S. Food and Drug Administration

Is FSVP optional if my supplier is GFSI certified
No. Third-party certifications can be used as verification activities, but you still need an FSVP and proper entry declarations. U.S. Food and Drug Administration

My broker files entries. Are they my FSVP importer
Only if that broker is named as the FSVP importer and has agreed to take on the legal program responsibilities. Usually the U.S. buyer or consignee is the FSVP importer. Decide this deliberately. U.S. Food and Drug Administration

What happens if FDA refuses my shipment
A refused shipment must be exported or destroyed under CBP and FDA supervision within strict timelines. Avoid this outcome with pre-screening and strong documentation. U.S. Food and Drug Administration

Beyond our history and licensure, Stile Associates has earned quality certifications that are a direct benefit to clients. The company is C-TPAT certified, a recognition from U.S. Customs and Border Protection (CBP) of a commitment to security and compliance. This certification offers tangible benefits, including faster clearance times and a lower likelihood of physical inspections, which directly reduces delays and disruptions to the supply chain. Additionally, Stile Associates is IATA-CNS and hazardous materials certified, demonstrating a comprehensive capability to handle a wide range of specialized shipments with the utmost care and professionalism.

Final Call to Action:

Ready to take control of your shipping costs?

Let’s talk. Contact Stile Associates for a free consultation and let our experts audit your current process, to help you streamline your operations, stay compliant, and save money.

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