US FDA Food Facility Registration
Any facility outside the USA that manufactures, processes, packs or holds food for the American market must register with the FDA and appoint a US Agent as its domestic point of contact. Registration itself is free; the US Agent is a commercial arrangement.
- Issued by
- US Food and Drug Administration (FDA)
- Typical time
- 3–10 working days once the US Agent is appointed
- Government fee
- None — the FDA charges no fee for food facility registration. A US Agent's fee is separate and commercial
- Validity
- Two years — renewal runs 1 October to 31 December of every even-numbered year
Who needs it
Every Indian food exporter shipping to the United States — including processed foods, spices, rice, tea, seafood and dietary supplements. It applies to the facility, so a trader using a third-party processor needs that processor registered too.
Documents required
- Facility name, physical address and FSSAI details
- IEC certificate
- Product categories per the FDA's classification
- Details of the owner, operator or agent in charge
- A US Agent with a physical US address who accepts the appointment
How it works
- 1
Confirm the facility and its categories
The FDA registers facilities, not exporters, and its product categories do not map neatly onto FSSAI's. We work out what has to be registered and under which categories.
- 2
Appoint a US Agent
A foreign facility cannot register without one — the Agent is FDA's point of contact in the United States and must confirm the appointment.
- 3
Register with the FDA
Filed through the FDA's system; a registration number is issued. No FDA fee is payable.
- 4
Track the renewal
Registration lapses unless renewed between 1 October and 31 December of every even-numbered year — the next window is this October. We diarise it.
Frequently asked questions
Does the FDA charge for food facility registration?
No. The FDA itself charges no fee. Costs come from the US Agent appointment and from whoever prepares the filing — which is worth knowing, because some agencies present the whole amount as if it were a government fee.
What happens if I ship without registering?
The FDA and US Customs can detain the consignment — with detention charges payable by the exporter until registration is confirmed — or order its destruction. It is not a paperwork formality.
When do I have to renew?
Every two years, in the window from 1 October to 31 December of even-numbered years. A missed renewal means the registration expires and shipments can be held at the border.
Is FSSAI enough for exporting to the USA?
No. FSSAI is India's licence to operate a food business; FDA registration is America's requirement to bring food into the United States. Food exporters to the USA need both.
Other registrations
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