Exporting olive oil to the United States. Two obligations wine doesn't have.

Olive oil enters the United States like any other FDA-regulated food, and that's exactly why it has two obligations wine doesn't. The supplier verification programme and the nutrition panel.

This page is part of exporting olive oil, which covers the EU marketing standards and the main markets, and goes into detail on the US market alone. For what every shipment leaving the EU has in common, see the documents that go with a shipment.

How to export olive oil to the United States: the five steps

Exporting olive oil to the United States takes five steps: the olive mill or packer registered with the FDA with a US agent, an importer with its own FSVP, a label with the nutrition panel or the small-volume exemption, prior notice before every arrival, and renewing the registration in even-numbered years.

Step	Who does it	The rule
Facility registrationFDA, with a US agent	The Italian olive mill or packer.	21 CFR 1.230 and 1.227: before producing for that market.
FSVPforeign supplier verification	The importer, using the information the olive mill provides.	21 CFR 1.502: for every imported food.
Nutrition panelNutrition Facts	The party preparing the label, unless the small-volume exemption applies.	21 CFR 101.9(a) and (j)(18).
Prior noticeFDA	Who submits it is agreed in writing with the importer.	21 CFR 1.279: from 2 to 8 hours before arrival.
Registration renewaleven-numbered years	The olive mill or packer.	21 CFR 1.230(b): from 1 October to 31 December.

The FSVP: the importer's programme that's really about the olive mill

The FSVP, the Foreign Supplier Verification Program, is how a US importer assures the FDA that its foreign supplier produces the food with the same level of public health protection required in the United States. 21 CFR 1.502 requires it for every imported food, and olive oil is included.

“for each food you import, you must develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection” (21 CFR 1.502(a))

The programme belongs to the importer, but the assurances are about how the olive mill produces. That's why a serious importer asks for documents on your process before the first order, and a mill that has them ready shortens the negotiation. The question to ask straight away is which documents they want, in what language and how often.

This is the main difference from wine in the United States. 21 CFR 1.501(e) exempts from the FSVP the alcoholic beverages of wineries required to register with the FDA, and lets other foods from the same winery in only if they're prepackaged and below 5% of its sales. Oil sold by an olive mill gets neither exemption.

The American nutrition panel on olive oil

Olive oil sold in the United States carries a nutrition panel in the American format, Nutrition Facts, unless it's exempt. 21 CFR 101.9(a) says nutrition information must be provided for all products intended for human consumption and offered for sale, and that for packaged foods it goes on the label in the format set by the same section.

The European table isn't enough, because the format and rules are those of 21 CFR 101.9. The American label is built on top of the European base, which for olive oil includes the marketing standards described in the main guide to olive oil; the differences between markets are in export labelling, market by market.

The small-volume exemption: 100 employees and 100,000 units

A small olive mill can be exempted from the nutrition panel for a product. 21 CFR 101.9(j)(18)(ii) exempts a product for 12 months if, over the previous 12 months, the business averaged fewer than 100 full-time employees and sold fewer than 100,000 units of that product in the United States.

The exemption is claimed with a notice to the FDA before the period starts, and the manufacturer, packer or distributor can file it. Only a business that isn't the importer, has fewer than 10 full-time employees and sells fewer than 10,000 units a year of that product doesn't need to file.

Two conditions often get forgotten. With the exemption, the label and advertising must not carry nutrition information or nutrient content or health claims. And if the thresholds are exceeded during the period, 21 CFR 101.9(j)(18)(iii) gives 18 months to put the panel on the label.

Your case	Conditions	What you need
Exempt, no notice	You aren't the importer, fewer than 10 employees, fewer than 10,000 units a year.	No panel and no notice, but no nutrition claims on the label.
Exempt, with notice	Fewer than 100 employees and fewer than 100,000 units in the United States in 12 months.	Notice to the FDA before the period starts, for each product.
Not exempt	Either threshold exceeded.	Nutrition Facts panel on the label.

The olive mill's FDA registration and renewal in even-numbered years

An olive mill or packer producing oil for the United States registers with the FDA before it starts, as 21 CFR 1.230 requires, and names a US agent. 21 CFR 1.227 requires a person who lives or has a place of business there and is physically present: not a mailbox or an answering machine.

Registration is renewed between 1 October and 31 December of each even-numbered year, and in 2026 the window runs from 1 October to 31 December. Under 21 CFR 1.241(b), if renewal is missed the FDA considers the registration expired and treats the facility as if it had never registered.

Prior notice: how many hours before arrival

Every shipment of olive oil to the United States is announced to the FDA with a prior notice, confirmed before arrival. 21 CFR 1.279 sets the minimum lead time before arrival at the port: 2 hours by road, 4 by rail or air, 8 by sea. It can't be submitted more than 30 days ahead via ABI/ACE, or more than 15 via the FDA portal.

The hours are counted in the time zone of the port of arrival. Who submits the prior notice, the importer or their customs broker, is agreed in writing before the ship is booked. The downloadable sheet works out the latest moment and the first day you can submit it.

US duty on olive oil

The US duty on olive oil is deliberately left off this page. You look it up in the US Harmonized Tariff Schedule, the HTS published by the U.S. International Trade Commission, using the code for your product and on the day you make the offer. Who pays it depends on the term written in the offer, as explained in Incoterms: who pays for what.

The template, to download

One file, three sheets. The first is the checklist of steps, with the section of the regulations next to each line. The second tells you, from your headcount and units sold, whether the product qualifies for the nutrition panel exemption and whether you need to file a notice. The third works out the prior notice dates from the day and time of arrival.

File	Contents	Link
Olive oil to the United StatesExcel, three sheets	Fourteen checklist lines with their sources, the nutrition exemption check and the prior notice calculation.	olio-stati-uniti-checklist-en.xlsx

The files are free. There's no form in the way, we don't ask for an email address, and we don't get notified when anyone downloads them. Duty is deliberately left out of the sheet: it changes with the tariff code and the date.

Questions and answers