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

Olive oil enters the United States like any other food regulated by the FDA, and for that very reason it has two obligations wine doesn't have. The supplier verification programme and the nutrition facts 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 outside the EU has in common there are the documents that go with the shipment.

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

To export olive oil to the United States you need five steps: the mill or packer registered with the FDA with an agent in the United States, an importer with its own FSVP, a label with the nutrition facts panel or the small-volume exemption, prior notice before every arrival and renewal of the registration in even-numbered years.

Step	Who does it	The rule
Facility registrationFDA, with an agent in the United States	The Italian mill or packer.	21 CFR 1.230 and 1.227: before producing for that market.
FSVPforeign supplier verification	The importer, with the information the mill provides.	21 CFR 1.502: for each imported food.
Nutrition facts panelNutrition Facts	Whoever prepares 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 mill or packer.	21 CFR 1.230(b): from 1 October to 31 December.

The FSVP: the importer's programme that concerns the mill

The FSVP, Foreign Supplier Verification Program, is the programme through which the 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 each imported food, and olive oil falls within it.

«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 concern how the mill produces. That is why a serious importer asks for documents on the 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 with 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 admits the winery's other foods only if prepackaged and below 5% of its sales. An oil sold by an olive mill has none of these exemptions.

The American nutrition facts panel on olive oil

Olive oil sold in the United States carries the nutrition facts panel in the American format, Nutrition Facts, unless exempt. 21 CFR 101.9(a) states that 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 is not 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 olive oil pillar page; the differences between markets are in the export label, market by market.

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

A small mill can be exempted from the nutrition facts panel for a product. 21 CFR 101.9(j)(18)(ii) exempts for 12 months the product of a business that, in the previous 12 months, had on average 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 notification to the FDA before the period starts, and the manufacturer, packer or distributor can file it. Only a business that is not the importer, has fewer than 10 full-time employees and sells fewer than 10,000 units a year of that product does not need to notify.

Two conditions are often forgotten. With the exemption, 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 is needed
Exempt, no notification	You are not the importer, fewer than 10 employees, fewer than 10,000 units a year.	No panel and no notification, but no nutrition claims on the label.
Exempt, with notification	Fewer than 100 employees and fewer than 100,000 units in the United States over 12 months.	Notification to the FDA before the period, for each product.
Not exempt	One of the two thresholds exceeded.	Nutrition Facts panel on the label.

FDA registration of the mill and renewal in even-numbered years

The mill or packer producing olive oil for the United States registers with the FDA before starting, as required by 21 CFR 1.230, and designates an agent in the United States. 21 CFR 1.227 requires a person residing or with a place of business there, 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 the renewal is missing the FDA considers the registration expired and treats the facility as if it had not registered.

Prior notice: how many hours before arrival

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

The hours are counted on the time at the port of arrival. Who submits prior notice, the importer or their customs broker, is agreed in writing before booking the ship. The downloadable sheet works out the last useful moment and the first day it can be submitted.

The duty on olive oil in the United States

The US duty on olive oil is not on this page, on purpose. It is read on the Harmonized Tariff Schedule of the United States, the HTS of the U.S. International Trade Commission, with your own heading code and on the day you make the offer. Who pays it is decided by the Incoterm, as explained in Incoterms: who pays what.

The template, to download

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

File	What it contains	Link
Olive oil in the United StatesExcel, three sheets	Fourteen checklist lines with the source, the nutrition exemption check and the prior notice calculation.	olio-stati-uniti-checklist.xlsx

The files are free. There is no form in front of them, we don't ask for an address and we receive no notification when someone downloads them. The duty is not in the sheet, on purpose: it changes with the tariff heading and with the day.

Questions and answers