The short answer
Spain is the world’s largest olive oil producer and a major exporter of table olives, wine, canned vegetables, pimentón, cured meats and cosmetics to the U.S. Most problems at the border come from authenticity, canned-food filings and labels.
What Spanish exporters should watch for
🫒 Olive oil
FDA watches olive oil for economic adulteration — oils blended or mislabeled for profit — under Import Alert 99-47, updated in October 2026. Keep authenticity and grade test results for each lot, and make sure the grade on the label matches.
🥫 Olives and canned vegetables
Table olives, piquillo peppers and other canned or jarred vegetables may need FCE registration and SID process filings, depending on the product’s acidity and process. File before the first shipment.
🌶️ Pimentón and spices
Paprika and spices are tested for Salmonella (Import Alert 99-19), mycotoxins and illegal colors. Cured ham and other meat products are regulated by USDA FSIS, not FDA.
🍷 Wine and cosmetics
Wineries register with FDA, with labels approved by TTB. Cosmetics need MoCRA facility registration and product listing; the EU Responsible Person does not count in the U.S.
Common reasons Spanish shipments are stopped
- Economic adulteration concerns in olive oil
- Canned or jarred foods without FCE/SID filings
- Salmonella in paprika and spices
- Labeling — EU nutrition panel, E-numbers, metric-only weights
- Cosmetics not registered or listed under MoCRA
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer 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 Spanish table olives need FCE and SID?
It depends on the product. Olives packed in hermetically sealed containers that are low-acid or acidified foods need FCE registration and an SID filing for each process; products naturally acid enough may be exempt. The olive’s pH and process decide, so check before shipping.
Does Spanish jamón need FDA registration?
No. Cured ham and other meat products are regulated by USDA FSIS, and only plants approved under the USDA system can export them to the U.S. FDA registration applies to the other foods a Spanish company exports, such as olive oil or olives.
Sources
- FDA — Import Alerts by Publish Date
- FDA — Acidified & Low-Acid Canned Foods (LACF) registration
- FDA Import Alert 99-19 — Salmonella (notes separate alerts for black pepper from India and Brazil)
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.