FDA import of food and supplements from China involves product and facility requirements plus per-shipment filings. This guide maps the steps and who is responsible for each.
What FDA imports cover
In everyday terms, an FDA import means food, dietary supplements and related products arriving into the United States from a foreign supplier. It is not a single task — it is a stack of product-level requirements, facility-level requirements and per-shipment filings that travel with every container you move.
Product identity matters before you plan freight. Vitamin gummies, herbal powder and a canned beverage each carry different labeling, record and storage expectations. Getting the product identity right at the start shapes the rest of the paperwork, so sort the goods into clear categories before you ask for a rate.
Product and facility requirements
Foreign food facilities that ship to the US must be registered, and the importer is expected to know who they are dealing with. On top of that, the product itself needs US-market labeling and the product records that back it up. None of this is freight — but if it is not in place when the cargo moves, the freight stops being the problem.
Per-shipment filings
Three filings run on every ocean shipment of food or supplements. Prior notice tells FDA the goods are coming, and for ocean cargo it must be submitted at least 8 hours before arrival. The Importer Security Filing (ISF, often called 10+2) goes in earlier still — no later than 24 hours before the cargo is laden on board the vessel. Customs entry is filed around arrival and carries the FDA-related data CBP and FDA need to screen the shipment.
Getting the order and timing right is what separates a smooth release from a slow hold. Filings that land late trigger penalties and delays, and they cannot always be fixed after the fact. Build the filing timeline around the sailing, not around the port call.
Who is responsible
This is where most importers get confused. The importer of record owns the compliance decisions and the records, including FSVP. The forwarder owns the freight-side coordination — booking, documentation handover and the day-to-day chase across carriers and warehouses. The licensed customs broker files the entry. Each role is distinct, and a good first question is asking your forwarder to map them on paper.
| Task | Who owns it | Notes |
|---|---|---|
| Foreign food facility registration | Foreign producer / importer arranges | The supplying facility must be registered with FDA. |
| Prior notice | Importer or broker, coordinated with the forwarder | At least 8 hours before ocean arrival. |
| ISF (10+2) | Importer, filed through the customs broker | No later than 24 hours before cargo is laden on board. |
| Customs entry (ACE / CBP 7501) | Licensed customs broker | Filed at or after arrival, with FDA-related data. |
| FSVP | US importer of record | Supplier verification, before and after import. |
| Document pack | Forwarder coordinates; importer retains | Invoice, packing list, bill of lading, product records. |
Timeline and documents
Work backward from the arrival date. ISF happens before loading; prior notice happens in the final hours before arrival; entry happens at the port. The entry summary is normally completed within 10 days after release. Keep a document pack for every shipment — commercial invoice, packing list, bill of lading, product records and filing confirmations — so that if CBP or FDA asks a question months later, you are not reconstructing it from memory.
Frequently asked questions
Who files the prior notice?
Prior notice is coordinated as part of the import process and is typically handled by the importer or their customs broker, using product and carrier data the forwarder supplies. Confirm exactly who submits it with your importer and forwarder before the first sailing; for ocean cargo it must be in at least 8 hours before arrival.
What is the importer of record responsible for?
The importer of record carries the compliance obligations for the shipment: product and labeling decisions, records, and FSVP arrangements for the foreign supplier. The forwarder coordinates freight and filing data with the importer, but the compliance decisions themselves sit with the importer and cannot be outsourced.
Where can I check the official requirements?
FDA and the electronic Code of Federal Regulations (eCFR) are the authoritative sources. The prior notice rule sits in 21 CFR Part 1, FSVP in 21 CFR Part 1 Subpart L, and CBP’s rules cover ISF and entry. Always read the current text before relying on a summary, because the details change over time.
Related reading
- FDA import preparation
- Document pack
- Food shipping services
- Supplement shipping services
- US customs clearance process
- Customs clearance fees in your quote
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