Your FDA food facility registration

An FDA food facility registration number identifies a facility — a place that manufactures/processes, packs or holds food for consumption in the United States. FDA issues it once the registration is confirmed, and you are considered registered once FDA sends you the confirmation and number (21 CFR 1.231(a)(7)).

Who must register:

• The owner, operator or agent in charge of a domestic or foreign facility that manufactures/processes, packs or holds food for consumption in the United States, unless an exemption in 21 CFR 1.226 applies (21 CFR 1.225(a))
• A facility is an establishment under one ownership at one general physical location (21 CFR 1.227)
• Exempt, among others: a foreign facility whose food is further manufactured or packaged by another facility outside the United States (adding a label does not count), farms, retail food establishments and restaurants (21 CFR 1.226)
• Register before the facility starts to manufacture, process, pack or hold food for the US (21 CFR 1.230(a))

INFO: An importer that never holds food. The duty to register attaches to a facility (21 CFR 1.225), and subpart H does not mention importers at all. Read that way, an importer of record that has no warehouse and does no packing or processing of its own may have no facility to register. This is a reading of the rule, not an exemption it states — confirm it for your business with FDA or your adviser. An importer's own warehouse holds food, so it is a facility.

Renewing: a registration is renewed every other year, between October 1 and December 31 of each even-numbered year (21 CFR 1.230(b)). If it is not renewed in that window, FDA considers the registration expired, and a facility with an expired registration is considered to have failed to register (21 CFR 1.241(b)). If nothing has changed, FDA allows an abbreviated renewal (21 CFR 1.230(c)). Registration and renewal must be submitted electronically unless FDA has granted a waiver (21 CFR 1.231(a)(2), 1.245), through FDA's online registration system at fda.gov/furls (21 CFR 1.231(a)(1)).

Keeping it current:

• Any change to the registration information (for example a new operator, agent in charge or U.S. agent): update the registration within 60 calendar days (21 CFR 1.234(a))
• A new owner: the former owner cancels the registration within 60 calendar days and the new owner submits a new registration (21 CFR 1.234(b))
• Closing, or no longer supplying food for the US: cancel within 60 calendar days (21 CFR 1.235(a))

U.S. agent (foreign facilities). A foreign facility names a U.S. agent, who must live in or keep a place of business in the United States. A mailbox, answering machine or answering service cannot be the U.S. agent (21 CFR 1.227). FDA gives a foreign facility its number only after the U.S. agent confirms (21 CFR 1.231(a)(5)).

Not the same as the importer identifier at entry. For FSVP, each line entry must carry the importer's name, email address and "unique facility identifier recognized as acceptable by FDA" (21 CFR 1.509(a)). That identifies you as the importer; it is not your facility registration number. FDA's guidance names the identifiers it accepts; the regulation itself names none. See FSVP basics for food importers for the rest of FSVP.

What Aleph does:

• Keeps your company's registration number on file, on every plan, Free included
• Lets your company's owners and managers add or correct it; every change is recorded with the old and the new number
• While the renewal window is open, shows the dates on the FDA registration page and, if your number is on file in Aleph, a reminder on your dashboard and Alerts page, due December 31

Aleph does not file, renew or cancel registrations with FDA, does not look your number up with FDA, and does not act as anyone's U.S. agent. The reminder stays for the whole window because Aleph cannot see whether you have renewed.