The short answer
When food or a dietary supplement is shipped to the United States, four different roles are involved. Two belong to customs (getting the goods through the border and paying duties) and two belong to FDA (food safety and registration). Exporters often assume one company covers all of them — usually “the broker” — and that is where shipments get held.
| Role | Who appoints them | What they do | Rule | Orionex? |
|---|---|---|---|---|
| U.S. Agent | The foreign facility | FDA's point of contact for your facility; listed on your registration | 21 CFR 1.227, 1.232 | Yes |
| Customs broker | Usually the importer of record | Files the customs entry with CBP, classifies the goods, sends FDA data with the entry | 19 CFR Part 111 | No — a licensed broker |
| Importer of record | Owner or purchaser of the goods | Legally responsible for the customs declaration, duties, fees and bond | 19 U.S.C. 1484 | No — usually your buyer |
| FSVP importer | US owner or consignee at entry | Verifies that each foreign supplier meets US food safety rules; keeps records | 21 CFR 1.500, 1.509 | Yes, as your agent |
Add one more task that is not really a “role”: Prior Notice. It must be filed with FDA for every food shipment before it arrives, and anyone with the right information can file it (21 CFR 1.278) — the exporter, the importer, the broker or a consultant.
1. The U.S. Agent — your facility's contact with FDA
Every foreign facility that manufactures, processes, packs or holds food for US consumption must register with FDA and name a U.S. Agent — a person or company that lives in, or keeps a place of business in, the United States. The U.S. Agent is listed on your registration and is the person FDA contacts about your facility, including in an emergency.
- Appointed by: you, the foreign facility
- Does: receives and passes on FDA communications; responds to FDA on your behalf
- Does not: file customs entries, pay duties or take ownership of the goods
Read more in What Is a U.S. Agent?
2. The customs broker — files the entry
A licensed customs broker prepares and files the customs entry with US Customs and Border Protection (CBP). For food, the entry also carries FDA information — product codes, the manufacturer's registration, the Prior Notice confirmation and the FSVP importer — which CBP passes to FDA for screening.
- Appointed by: normally the importer of record, through a power of attorney
- Does: tariff classification, entry filing, transmitting FDA data
- Does not: register your facility, review your labels or verify your suppliers
3. The importer of record — responsible for the customs side
The importer of record (IOR) is the party legally responsible for the import in the eyes of CBP: making sure the declaration is correct, paying duties and fees, and holding a customs bond. It is normally the owner or purchaser of the goods — very often your US buyer or distributor, or your own US company if you have one.
- Appointed by: whoever owns or buys the goods for import
- Does: customs compliance, duties, bond; usually hires the broker
- Does not: automatically take on your FDA registration or U.S. Agent role
4. The FSVP importer — verifies your food safety
Under FDA's Foreign Supplier Verification Program, the FSVP importer must verify that each foreign supplier produces food meeting US safety standards, and keep records FDA can inspect. The FSVP importer is the US owner or consignee of the food when it enters; if there is none, it is the US agent or representative of the foreign owner, who confirms this in writing.
The FSVP importer's name, email and unique facility identifier (a DUNS number) must be given for each entry of food covered by FSVP (21 CFR 1.509).
- Usually: the same company as the importer of record — but the two roles come from different laws
- Does: hazard analysis, supplier evaluation and ongoing verification, record keeping
Read more in FSVP for Importers.
Can one company hold several roles?
Yes — and it is common. Typical combinations:
- US distributor = importer of record + FSVP importer, with its own broker
- Exporter with its own US company = importer of record + FSVP importer
- Orionex = U.S. Agent + FSVP agent + Prior Notice + registration and labels — the FDA side, alongside your broker
What matters is that every role is assigned to someone and that everyone knows who it is before the goods ship.
Five mistakes that hold shipments
- 1“The broker handles FDA.”The broker files the data; it does not create your registration, approve your labels or run FSVP.
- 2No FSVP importer agreed.Your buyer assumes you have it covered, you assume they do — and the entry has no valid FSVP importer.
- 3Registration not renewed.Food facility registrations must be renewed between October 1 and December 31 of every even-numbered year. Shipments from a facility without a valid registration can be held.
- 4Prior Notice late or wrong.It must arrive at least 8 hours before arrival by sea, 4 by air or rail, 2 by road — with the correct registration number and product details.
- 5Labels checked after shipping.Missing allergen declarations or the wrong nutrition panel are among the most common reasons food is detained.
Example: a coffee exporter shipping to a US distributor
Who does what for one container of roasted coffee from Brazil to New Jersey
- Exporter (Brazil): registers its facility with FDA and names Orionex as U.S. Agent; has labels reviewed before printing
- Orionex: keeps the registration current, acts as U.S. Agent, files Prior Notice and sends the confirmation to the broker
- Distributor (New Jersey): is the importer of record and the FSVP importer — or appoints Orionex as its FSVP agent to build and keep the supplier file
- Customs broker: hired by the distributor; files the entry with the FDA data
See all US food import requirements, or get yours in writing — free.
Checklist before your first shipment
- FDA food facility registration active, with a U.S. Agent named
- Labels reviewed against FDA rules
- Importer of record and customs broker agreed with your buyer
- FSVP importer agreed in writing, with name, email and DUNS ready for the entry
- Prior Notice filed for the shipment, confirmation sent to the broker
Frequently asked questions
Can my customs broker be my U.S. Agent?
Only if the broker agrees to take on the role and is listed on your FDA registration as U.S. Agent. Filing customs entries does not make a broker your U.S. Agent, and many brokers do not offer the service.
Is the importer of record the same as the FSVP importer?
Often, but not always. The FSVP importer is the US owner or consignee of the food at the time of entry. That is frequently the same company as the importer of record, but the two roles come from different laws: customs law for the importer of record, FDA's FSVP rule for the FSVP importer.
Does the U.S. Agent pay customs duties?
No. The U.S. Agent is FDA's contact for your facility. Duties, fees and the customs bond are the importer of record's responsibility.
Who files Prior Notice?
Any person with knowledge of the required information can submit Prior Notice — the exporter, the importer, the customs broker or a consultant such as Orionex. What matters is that it is filed correctly and on time for every shipment.