FDA Requirements for Importing Ethiopian Green Coffee into the US

Which FDA Rules Apply to a Green Coffee Shipment?

These rules sit in Title 21 of the US Code of Federal Regulations, Part 1. They are separate from customs duties and tariffs, which are set by the US tariff schedule and administered by US Customs and Border Protection (CBP); your customs broker confirms the classification and any duty for each entry. For the commercial side of buying from Ethiopia — contracts, FOB Djibouti terms, export documents and transit times — see our wholesale import guide and the US wholesale page.

Rules summarised from 21 CFR Part 1 as published on eCFR (version of 1 October 2026) and FDA guidance pages, reviewed 15 October 2026. This is general information, not legal or regulatory advice for a particular shipment.

1. FDA Prior Notice: Deadlines and What It Contains

Prior Notice applies to all food imported or offered for import into the United States — and FDA's scope expressly includes trade samples and quality-assurance/quality-control samples (21 CFR 1.277). A green coffee container and a sample parcel for cupping are both covered. The notice only counts as submitted once FDA confirms it and issues a Prior Notice (PN) Confirmation Number (21 CFR 1.279(d)).

There is also an earliest filing date: no more than 30 calendar days before arrival when filed through CBP's ABI/ACE system (the route customs brokers normally use), or 15 days when filed directly in FDA's Prior Notice System Interface (21 CFR 1.279(b)).

The notice identifies the coffee by its FDA product code, common name and quantity; the manufacturer (with its registration number) for food no longer in its natural state, or the grower or consolidator for food that is; the shipper; the country it is shipped from; and the anticipated port and date of arrival (21 CFR 1.281(a)). In practice your broker files it, using the details on the exporter's commercial invoice and bill of lading.

Samples sent by international mail

For food sent by international mail, Prior Notice must be filed before the parcel is posted, and the PN Confirmation Number must appear on the customs declaration (CN22/CN23) (21 CFR 1.279(c) and (e)). From 1 October 2026 a mail Prior Notice must also give the name of the mail service and the tracking number (21 CFR 1.281(b)). If you request green coffee samples, agree with the sender who files the notice before anything ships.

2. Food Facility Registration — and the 2026 Renewal Window

Any facility, in the US or abroad, that manufactures/processes, packs or holds food for consumption in the United States must register with FDA before it starts doing so (21 CFR 1.230(a)). "Holding" means storage and activities incidental to storage (21 CFR 1.227). Farms are exempt (21 CFR 1.226(b)). A foreign facility is also exempt if its food is further processed by another facility outside the US before export (21 CFR 1.226(a)) — which does not help when the green coffee is roasted after it reaches the US.

A foreign facility's registration must include a unique facility identifier and the name and contact details of its US agent (21 CFR 1.232).

Renewal is due now. Registrations must be renewed every other year, between 1 October and 31 December of each even-numbered year (21 CFR 1.230(b)). 2026 is a renewal year, so for shipments planned for the 2026/27 crop, ask your exporter for the FDA registration number of the facility that last packs or holds your coffee and confirm it has been renewed in this window.

3. FSVP: Who the Importer Is and the Green Coffee Provision

Under the Foreign Supplier Verification Program rule, the "importer" is the US owner or consignee of the food when it is offered for import. If there is none, it is the US agent or representative of the foreign owner, who must sign a statement consenting to act as importer (21 CFR 1.500). That importer must develop, maintain and follow an FSVP for each food it imports (21 CFR 1.502), and must be identified electronically — name, email address and a unique facility identifier — for each line entry filed with CBP (21 CFR 1.509(a)).

Green coffee has a specific route through the rule. Where the importer identifies a hazard requiring a control and determines and documents that the type of food could not be consumed without that control — the regulation's own examples are "raw agricultural commodities such as cocoa beans and coffee beans" — the importer is not required to carry out the foreign supplier evaluation or supplier verification activities (21 CFR 1.507(a)(1)). FDA's FSVP overview gives coffee beans as an example of this circumstance.

That is a documented determination, not a blanket exemption: the importer still has an FSVP, keeps the record, and is identified at entry. Many roasters use a consultant or their broker to set this up; FDA's FSMA Technical Assistance Network answers questions on the rule.

Pre-Shipment Checklist for US Buyers

Alongside these FDA items, each shipment travels with the export documents listed in our import guide. Quality and grade are a separate question — see the Grade 1 vs Grade 2 guide.

Sources

• 21 CFR Part 1, Subpart I — Prior Notice of Imported Food (eCFR)
• 21 CFR Part 1, Subpart H — Registration of Food Facilities (eCFR)
• 21 CFR Part 1, Subpart L — Foreign Supplier Verification Programs (eCFR)
• FDA — Filing Prior Notice for Imported Foods
• FDA — Registration of Food Facilities and Other Submissions
• FDA — FSMA Final Rule on Foreign Supplier Verification Programs (FSVP)

Regulations change. Check the current eCFR text and FDA guidance, and confirm requirements for a specific entry with your customs broker, before you ship.