Does imported food need FDA facility registration?

The requirement sits with the owner, operator, or agent in charge of a facility — domestic or foreign — that is engaged in the manufacturing, processing, packing, or holding of food for consumption in the United States. A foreign facility in that position has to register with FDA unless one of the exemptions applies. Registration is a one-time account for the facility, renewed on FDA's schedule, not a per-shipment step.

A facility, in the rule's own words, is any establishment or structures under one ownership at one general physical location that manufactures, processes, packs, or holds food for U.S. consumption. Transport vehicles that only hold food in the usual course of business as carriers are not facilities.

Section 1.226 lists the facilities the subpart does not reach: farms; retail food establishments; restaurants; nonprofit food establishments that prepare or serve food directly to consumers; certain fishing vessels; and facilities regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the meat, poultry, or egg-products inspection laws.

One exemption catches people out: a foreign facility whose food then undergoes further manufacturing or processing by another facility outside the United States is exempt — but only if that further processing is more than de minimis. Merely adding labeling does not count, so the upstream facility can still owe registration.

Food carries up to three separate FDA import requirements, and they are easy to blur. Facility registration is about the facility. Prior notice is filed for each individual shipment before it arrives. The Foreign Supplier Verification Program (FSVP) is the U.S. importer's own program for verifying the supplier. A food import can owe all three, and clearing one says nothing about the other two.

Registration is not FDA approval of the food, and this requirement is only one piece of the FDA picture. Premarket steps, labeling rules, and current good manufacturing practice are separate regimes a food product can still owe. A clear answer on facility registration frames the question, it does not close it.