FDA import requirement

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Does imported food need FDA facility registration?

In one line

Usually, yes. The foreign facility behind the food has to register with FDA if it makes, processes, packs or holds food for people or animals in the United States. Farms, restaurants, retail food stores and a few others are exempt. It's a sign-up for the facility, separate from the prior notice sent for each shipment.

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What is FDA food facility registration, and who registers?

It's a one-time sign-up for the facility, renewed on FDA's schedule. It's not a step for each shipment. The duty sits with the facility's owner, operator or agent in charge, in the U.S. or abroad.

In the rule's words, a facility is any place under one owner, at one general location, that makes, processes, packs or holds food for U.S. consumption. Trucks and other vehicles that only carry food as carriers aren't facilities.

Which facilities are exempt from FDA registration?

Farms, retail food stores and restaurants. Nonprofit food places that prepare or serve food straight to consumers. Certain fishing vessels. And facilities that the U.S. Department of Agriculture alone regulates, throughout, under the meat, poultry or egg-products laws.

One exemption catches people out. A foreign facility is exempt when another facility outside the United States processes its food further, but only if that processing is more than minor (de minimis). Just adding a label doesn't count. So a facility whose food is only labeled by another facility abroad can still have to register.

Is facility registration the same as prior notice or FSVP?

No. Food can owe three separate FDA import steps, and they're easy to mix up. Registration is about the place. Prior notice is sent for each shipment before it arrives. The Foreign Supplier Verification Program (FSVP) is the U.S. importer's own program for checking the supplier. A food import can owe all three, and clearing one says nothing about the other two.

Does registration mean FDA approved the food?

No. Registration is one piece of the FDA picture. Premarket steps, labeling rules and current good manufacturing practice are separate rules a food can still owe. A clear answer on registration starts the question; it doesn't close it.

Next step

Importing food? See which FDA steps apply to your food, with the rule for each — free.

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When this changes

Tell me when the rules on this page change

The rules on this page do change — an eFiling date, a list, a threshold. Leave an email and a short note goes out if one does: a few a year at most, one click to stop, and the address is used for nothing else. A summary of the guide and a link arrive now, as confirmation.