The short answer
Chile is a major winter supplier of fresh fruit to the U.S. — grapes, cherries, blueberries — and also ships farmed salmon, wine, walnuts, dried fruit and juice. Fresh fruit is shared between USDA and FDA; everything processed is FDA’s.
What Chilean exporters should watch for
🍇 Fresh fruit
Fresh fruit needs USDA APHIS entry approval and pest rules. On the FDA side, farms must meet the Produce Safety Rule, packing houses that are not part of a farm must register, and the U.S. importer needs an FSVP.
🐟 Farmed salmon
Salmon processors must register with FDA and follow the seafood HACCP rule. Farmed fish is checked for residues of veterinary drugs that are not allowed in U.S. seafood, so residue testing records matter.
🍷 Wine
Wineries must register with FDA as food facilities and file Prior Notice for each shipment. Label approval (COLA) and import permits are handled by TTB, not FDA.
🥜 Walnuts, dried fruit and juice
Nuts are checked for aflatoxins and Salmonella; dried fruit for sulfites that must be declared on the label. Juice processors must follow juice HACCP.
Common reasons Chilean shipments are stopped
- Drug residues in farmed salmon
- Undeclared sulfites in dried fruit
- Aflatoxins or Salmonella in nuts
- Juice HACCP not in place
- Labeling — Spanish-only labels, no Nutrition Facts
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent service 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 Chilean fresh fruit exporters need FDA registration?
Growers are generally exempt from facility registration as farms but must meet FDA’s Produce Safety Rule. Packing houses, coolers and processors that are not part of a farm must register with FDA and name a U.S. Agent. USDA APHIS rules also apply to fresh fruit.
Does a Chilean winery need FDA registration?
Yes. Wineries and other alcohol producers exporting to the U.S. must register with FDA as food facilities and file Prior Notice. TTB separately handles label approval and import permits.
Sources
- FDA — FSMA Final Rule on Produce Safety
- 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.