The short answer
Panama exports world-famous Geisha coffee, shrimp, tuna, pineapple, bananas and rum to the U.S. Seafood and fresh fruit have the most rules.
What Panamanian exporters should watch for
☕ Geisha and specialty coffee
Coffee mills, roasters and warehouses register with FDA and name a U.S. Agent; every shipment, including samples for buyers, needs Prior Notice. Roasted coffee for retail needs U.S. labels.
🦐 Shrimp and tuna
Seafood processors must follow seafood HACCP (21 CFR Part 123). Tuna needs histamine controls, and farmed shrimp is tested for unapproved drug residues.
🍍 Pineapple and bananas
Fresh fruit must be allowed by USDA APHIS and inspected at entry. Packing houses that handle other farms’ fruit register with FDA, and residues must be within U.S. limits.
🥃 Rum
Distilleries register with FDA and file Prior Notice. Label approval and permits are handled by TTB.
Common reasons Panamanian shipments are stopped
- Histamine in tuna
- Drug residues in farmed shrimp
- Pesticide residues on fresh fruit
- No Prior Notice for coffee samples
- No FSVP at the U.S. importer
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Do Panamanian coffee exporters need FDA registration?
Yes. Facilities that hull, roast, pack or store coffee for the U.S. must register with FDA and name a U.S. Agent. Farms that only grow and dry their own coffee may be exempt, but the mill or exporter usually is not.
What does Panamanian seafood need for the U.S.?
FDA facility registration with a U.S. Agent, a seafood HACCP plan (with histamine controls for tuna), English labels and Prior Notice for each shipment.
Sources
- eCFR — 21 CFR Part 123, Fish and fishery products (seafood HACCP)
- USDA APHIS — Fruits and vegetables import requirements (FAVIR)
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.