FDA US Agent for Foreign Food Facilities
Every foreign facility that manufactures, processes, packs or holds food for consumption in the United States must register with FDA and name a U.S. Agent who lives or keeps a place of business in the U.S. and is physically present there. Registrations must be renewed between October 1 and December 31 of each even-numbered year.
Who needs a U.S. Agent
- Foreign facilities that manufacture, process, pack or hold food, beverages, dietary supplements or animal food for U.S. consumption
- Exempt: facilities whose food undergoes further manufacturing or processing (beyond labeling or a de minimis step) at another foreign facility before export, under 21 CFR 1.226(a)
Deadlines
- Register before the facility starts handling food for the U.S. market
- Renew every even-numbered year, October 1 to December 31 (21 CFR 1.230(b))
- Update within 60 days of any change to required information, including the U.S. Agent (21 CFR 1.234)
Steps to register
- Get a Unique Facility Identifier (UFI). FDA currently accepts the DUNS number
- Choose a U.S. Agent and get their written agreement
- Your owner, operator or agent in charge submits the registration in FDA's FURLS Food Facility Registration Module
- FDA emails the U.S. Agent to verify the designation; the agent confirms
- Keep your registration number for prior notice filings
US Agent Desk prepares this data for your officer and serves as your U.S. Agent. Your company's own officer submits the registration in FDA's system.
Common mistakes
- Listing a U.S. Agent who never agreed to serve. FDA verifies the agent and may cancel the registration
- Missing the even-year renewal, which makes the registration expire
- Using an invalid or mismatched DUNS address
- Buying a "registration certificate": FDA does not issue them
By country
Food facility U.S. Agent for China · Food facility U.S. Agent for India · Food facility U.S. Agent for South Korea · Food facility U.S. Agent for Japan · Food facility U.S. Agent for Vietnam · Food facility U.S. Agent for Taiwan · Food facility U.S. Agent for Mexico · Food facility U.S. Agent for Italy · Food facility U.S. Agent for Germany · Food facility U.S. Agent for France · Food facility U.S. Agent for Spain · Food facility U.S. Agent for Turkey · Food facility U.S. Agent for Thailand · Food facility U.S. Agent for Indonesia · Food facility U.S. Agent for Brazil · Food facility U.S. Agent for Canada · Food facility U.S. Agent for United Kingdom · Food facility U.S. Agent for Israel · Food facility U.S. Agent for Malaysia · Food facility U.S. Agent for Pakistan