Your roadmap for the whole path — and the deep guide for each phase.
Here's the whole journey at a glance — each phase links to its detailed guide:
Determine whether your canned food is low-acid (LACF), acidified, or naturally acidic — this decides whether the FCE/SID path applies and which forms you'll use. A process authority should confirm it.
Which type is mine? ↓Complete Food Facility Registration, obtain your FCE, and file a scheduled process (SID) for each product. Foreign manufacturers file these — not the importer — and appoint a U.S. Agent.
Register a canning facility →A process authority establishes and validates the scheduled process behind each SID — the heat process for LACF, the pH control for acidified. This is usually the longest-lead step, so start it early.
How process filing works →Your label has to meet FDA requirements and match your formulation and the process on file. A label that doesn't align with your SID can hold a shipment on its own.
Labeling for export →Your U.S. importer holds FSVP; prior notice is filed before arrival, usually by the broker. With filings, validation, label, and import chain in place, you're ready to ship.
Prepare the shipment →This is the decision everything else hangs on. The two regulated categories follow different rules and different forms — pick yours to go deep:
Who files, and which form applies.
Filing responsibility →What your U.S. buyer verifies.
Importer & FSVP →Confirm everything before you ship.
Run the checklist →The risks and timeline up front.
First-timer guide →What goes wrong, and how to fix it.
Filing errors →Required for every foreign facility.
U.S. Agent →FDA Registration Assistance handles the full canned-food path: confirming classification, Food Facility Registration and U.S. Agent, FCE and scheduled process (SID) filing, process-authority coordination, and label review — so your product is compliant before it ships.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Food Facility Registration is available starting at $858. Trusted by companies across 135+ countries, with 15+ years of experience.
Five phases: classify your product as low-acid canned (LACF) or acidified, register your facility and obtain an FCE, file a scheduled process (SID) for each product validated by a process authority, make your label compliant, and complete the import chain — FSVP held by your U.S. importer and prior notice before arrival. Foreign facilities also need a U.S. Agent. Classification comes first because it determines everything after it.
No — only low-acid canned foods (finished pH above 4.6) and acidified foods (low-acid base brought to pH 4.6 or below with added acid) require FCE registration and scheduled process filings. A naturally acidic canned food generally doesn't. That's why classification is the first phase: it decides whether the FCE/SID path applies to you at all.
A low-acid canned food has a natural finished pH above 4.6 — canned vegetables, meats, seafood, prepared meals — and relies on heat for safety. An acidified food starts low-acid and has acid added to reach pH 4.6 or below — pickles, hot sauces, salsas — relying on acidity. A process authority should confirm the classification, since it drives which rules and forms apply.
FCE stands for Food Canning Establishment. It registers a physical plant that produces low-acid or acidified canned foods, and it's required before you can file a scheduled process. There's one FCE per plant, and it has to be in place before any SID can be filed against it.
The manufacturer, or an authorized FDA agent acting for it — not the U.S. importer, distributor, or broker. The importer relies on your FCE and SID for their own FSVP, but the filings themselves are the manufacturer's responsibility. This trips up exporters who assume their buyer handles it.
Yes. Every foreign facility that registers with FDA must designate a U.S. Agent as FDA's U.S.-based point of contact. The agent role is a contact function, distinct from the party that files your FCE and SID, though one provider often handles both. It's designated as part of your Food Facility Registration.
A process authority validates your process — determining the safe parameters and providing the documentation your scheduled process depends on. FDA doesn't "approve" your process; the process authority establishes and validates it, and that validation is what a SID rests on. It's typically the longest-lead part of the whole path.
Yes. Your label has to meet FDA requirements and match your formulation and the process on file. A label that's inconsistent with your SID can hold a shipment even when the FCE and SID are valid, so labeling isn't a formality tacked on at the end — it's part of the compliance package.
Your U.S. importer — the owner or consignee at entry — holds FSVP, not you as the foreign exporter. You support it by supplying your registration, FCE, SID, and process documentation. The obligation itself sits with the importer bringing the product into the U.S.
Prior notice is an FDA submission that has to be filed before an imported food shipment arrives, identifying the product, shipper, and importer. It's usually filed by the customs broker or importer through the customs system, and missing it can lead to refusal at the port.
In most cases, no. FCE, SID, prior notice, and labeling have to be right before export, and they can't be back-dated to rescue a shipment already in transit or at the port. That's why planning the whole path before you ship is the single most important thing you can do.
There's no single fixed number — it depends on your product, your facility, and how ready your information is. Food Facility Registration and the FCE and SID submissions are relatively quick; the process-authority validation behind each scheduled process is usually the long pole. The practical advice is to start validation early rather than treat it as a final step.
No. Registration and the FCE/SID filings are compliance steps, not an FDA approval or endorsement. FDA doesn't pre-approve foods or labels; the filings put your facility and validated process on record. Your product still has to meet all applicable requirements at import.
We handle the full canned-food path: confirming classification, Food Facility Registration and U.S. Agent, FCE and scheduled process (SID) filing, process-authority coordination, and label review — so your product is compliant before it ships. Starting at $858 for registration, for companies across 135+ countries. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.