The short answer
Olive oil is one of the foods FDA watches most closely for fraud — oils blended with cheaper oils or sold under a higher grade. Mills, bottlers and storage facilities need FDA registration, and the grade on the label must be truthful.
What exporters should watch for
🕵️ Fraud and Import Alert 99-47
FDA keeps Import Alert 99-47 for human food adulterated for economic gain, updated in October 2026. Olive oil blended with cheaper oils or mislabeled by grade is a classic example. Keep authenticity and grade test results for each lot.
🏷️ Grades
“Extra virgin”, “virgin” and “olive oil” must match the oil in the bottle. USDA has voluntary U.S. grade standards for olive oil; FDA treats a false grade or origin as misbranding.
🏭 Registration
Olive mills, refineries, bottlers and storage tanks that handle oil for the U.S. must register with FDA and name a U.S. Agent; each shipment needs Prior Notice, and the importer needs an FSVP.
📋 Labels
Labels need the name, net quantity in U.S. units and metric, Nutrition Facts, the name and place of business, and country of origin. Health claims must follow FDA rules.
Common reasons shipments are stopped
- Economic adulteration — blends or grade fraud
- Wrong grade or origin on the label
- Facility not registered or no Prior Notice
- Labeling — metric-only volume, no Nutrition Facts
- 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 product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Does olive oil need FDA approval?
No product approval is needed. The mill, bottler or storage facility must register with FDA and name a U.S. Agent, each shipment needs Prior Notice, and the label must be truthful about grade and origin. FDA can detain oil suspected of economic adulteration.
Who checks “extra virgin” claims in the U.S.?
USDA publishes voluntary grade standards, and FDA can act against olive oil that is adulterated or misbranded, including a false grade. Importers and retailers often require lab results showing the oil meets extra virgin criteria.
Sources
- FDA — Import Alerts by Publish Date
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- eCFR — 21 CFR Part 1 Subpart I, Prior Notice of Imported Food
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.