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FDA Requirements for Coffee Import

Registration, U.S. Agent, and the exact rules that apply to green, roasted, and instant coffee.

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Who Needs to Register

Any foreign facility that grows, dry-processes, roasts, grinds, blends, or packs coffee intended for the U.S. market must complete FDA Food Facility Registration. This applies at every stage — a dry mill washing and sorting green beans is in scope just as much as a roastery packaging retail bags.

This is facility-level, not shipment-level. One registration covers a facility; it doesn't need to be repeated per shipment (that's what Prior Notice is for — see our Prior Notice guide).

The U.S. Agent Requirement

Every registered foreign facility must name a U.S. Agent — a person or company physically located in the United States who can receive FDA communications on the facility's behalf, including in an emergency (such as a recall notice or import alert). Orionex serves this role for coffee exporters across green bean, roasted, and instant coffee categories.

What's Covered vs. What Isn't

ProductRegistration Required?
Green (unroasted) coffee beansYes
Roasted whole bean / ground coffeeYes
Instant / soluble coffeeYes
Flavored or blended coffeeYes
Cold brew concentrate / RTD coffeeYes

In practice, every commercial form of coffee destined for the U.S. requires registration — there's no processing-level exemption.

2026 renewal window: If your facility was registered in a previous even-numbered year, you must renew between October 1 and December 31, 2026, or the registration expires with no grace period. Check your exact renewal date →

Frequently Asked Questions

Does instant coffee need FDA registration too?

Yes — instant coffee is processed food, and the manufacturing or packing facility must be FDA registered with a U.S. Agent, same as green or roasted coffee.

Do I need to register if I only sell to a U.S. distributor?

Yes. Registration applies to the facility that manufactures, processes, packs, or holds the coffee — not the party you're selling to.

Related Guides

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