We work out which FDA rules apply to your product, tell you in writing, then take care of them — so your shipment clears the FDA side first time.
We'll email your requirements within 1 business day. A confirmation is on its way to .
Exporters are often told “your broker handles it”. A customs broker files the entry, but the FDA side has to be ready first — and it has its own responsible parties.
Which of these apply depends on your product, your facility and who imports it. We confirm that in writing before any work starts.
Facilities that manufacture, process, pack or hold food for US consumption must register with FDA, so FDA can identify and contact them in a public health event. Foreign facilities must also name a U.S. Agent. Registrations are renewed every two years (October–December of even years).
English labelling with statement of identity, net quantity, ingredients, Nutrition Facts (Supplement Facts for supplements), major allergens and the responsible business. Labelling errors are a common cause of detentions and import refusals.
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 identified on every customs entry.
FDA must be told about each food shipment before it arrives — at least 8 hours ahead by sea, 4 by air or rail, 2 by road. Shipments without adequate Prior Notice can be refused and held at the port.
Some products have extra rules on top of the four above. Pick yours for the details.
Product, where it's made and how it ships. We assess what applies, free.
Your requirements, who is responsible for each, and a clear fixed quote.
Registration, U.S. Agent, labels, FSVP and Prior Notice — handled for you.
Registration number, certificate and Prior Notice confirmation, ready for your broker.
FDA does not issue a general food import licence. What you need depends on your product: FDA food facility registration (with a U.S. Agent) for the facility that makes, packs or holds the food, Prior Notice for every shipment, an identified FSVP importer, and labels that meet FDA rules. Alcoholic beverages also need TTB permits and label approval, and meat, poultry and certain egg products fall under USDA rather than FDA. The customs entry itself is filed with CBP, usually by a licensed customs broker.
It is a listing that tells FDA who you are and how to reach you, required under section 415 of the FD&C Act and 21 CFR Part 1 Subpart H for facilities that manufacture, process, pack or hold food for US consumption. Registration does not mean FDA has approved your facility or products. It must be renewed every two years between October 1 and December 31 of each even-numbered year — the 2026 renewal window is open now.
Yes. A foreign facility must name a U.S. Agent who lives in, or keeps a place of business in, the United States. The U.S. Agent is FDA's point of contact for the facility, including in emergencies, and is listed on the registration. Our U.S. Agent service.
Prior Notice tells FDA about each food shipment before it arrives. It must be received at least 2 hours before arrival by road, 4 hours by air or rail and 8 hours by water; for international mail, before the parcel is sent. It can be filed up to 15 days ahead through FDA's Prior Notice System Interface, or 30 days through CBP's ACE. A shipment without adequate Prior Notice can be refused and held at the port.
Food sold in the US must be labelled in English: statement of identity, net quantity (US and metric units), ingredient list, Nutrition Facts (or Supplement Facts for dietary supplements), the major food allergens including sesame, and the name and place of business of the manufacturer, packer or distributor. Country of origin marking is a customs requirement. Health and nutrient claims must follow FDA rules.
The FSVP importer: the US owner or consignee of the food at the time of entry or, if there is none, the US agent or representative of the foreign owner. The FSVP importer's name, email and unique facility identifier are entered with each shipment. Orionex can act as your FSVP agent and keep the supplier verification records.
Tell us what you make and how it ships. You'll get your US requirements in writing, free, within 1 business day.
Get my requirements →