Exporting wine to the United States. The TTB looks at the label, the FDA looks at the winery.
Exporting wine to the United States means answering to two federal authorities. The TTB checks who imports and the label, the FDA checks the winery and the shipment.
You need an importer with a TTB basic permit. 27 CFR 1.20 prohibits engaging in the business of importing wine into the United States without a federal permit. For an Italian winery the first step is therefore choosing who imports: they hold the permit, and the label and customs clearance are tied to them.
The label is approved before printing. Under 27 CFR 4.40 bottled wine does not leave customs custody unless the person releasing it holds a certificate of label approval, the COLA, and unless the bottles carry labels identical to those on the certificate.
The winery registers with the FDA and renews in even-numbered years. 21 CFR 1.230 sets renewal between 1 October and 31 December of each even-numbered year, so in 2026 the window runs from 1 October to 31 December. A registration that is not renewed is considered expired by the FDA.
This page is part of exporting wine: the documents, who issues them and when they are needed, and covers a single market, the United States. What wine has in common with every shipment outside the EU, namely invoice, packing list and export declaration, is in the documents that go with the shipment.
How to export wine to the United States: the four steps
To export wine to the United States you need four steps, in the order they come up: an importer with a TTB basic permit, a COLA for each label, the winery registered with the FDA with an agent in the United States, and prior notice to the FDA before every arrival. The duty comes on top, and is read on the tariff of the day.
| Step | Who does it | The rule |
|---|---|---|
| Importer with a basic permitTTB | The US importer, who already holds the permit. |
27 CFR 1.20: without a permit no one may import wine to trade in it. |
| COLA for each labelTTB | Whoever releases the wine from customs, normally the importer. |
27 CFR 4.40: without a COLA bottled wine stays in customs custody. |
| Winery registrationFDA, with an agent in the United States | The Italian winery, before producing for that market. |
21 CFR 1.230 and 1.227: renewal in even-numbered years, agent physically present. |
| Prior notice for each shipmentFDA | Who submits it is agreed in writing with the importer. |
21 CFR 1.279: from 2 to 8 hours before arrival, depending on the mode of transport. |
Who can import wine into the United States: the TTB basic permit
In the United States only those holding a basic permit issued by the TTB, the Treasury Department bureau that regulates alcoholic beverages, may import wine. 27 CFR 1.20 states that no one, except under that permit, may engage in the business of importing wine, or sell or ship the wine so imported.
«No person, except pursuant to a basic permit issued under the Act, shall: (a) Engage in the business of importing into the United States distilled spirits, wine, or malt beverages» (27 CFR 1.20)
For an Italian winery the consequence is practical: the first negotiation is with an importer who already holds the permit. They are the one who releases the wine from customs, and the law ties the label certificate to whoever releases the wine. That is why changing importer after the first order costs more than choosing well beforehand.
What the wine COLA is, and who must hold it
The COLA is the certificate of label approval issued by the TTB, and without a COLA bottled wine stays in customs. 27 CFR 4.40 puts it this way: wine imported in containers may not be released from customs custody for consumption unless the person releasing it has obtained and holds a COLA.
The second half of the rule is the costly one: the bottles must carry labels identical to those shown on the certificate, or with only the changes the form authorises. You approve the label, then you print the lot. A lot printed before approval, with one detail different, is a lot that does not get through.
The certificate belongs to whoever applies for it. If an importer uses a COLA issued to someone else, every bottle must carry the name and address of the COLA holder, and the importer must be able to show it is authorised to use it. Anyone changing importer must therefore know beforehand whose certificate their labels are on.
The COLA covers wine with at least 7% alcohol by volume, imported in retail containers: the TTB says so on its page on labelling imported wine, updated 12 January 2026. Bulk wine, in containers not intended for retail sale, does not need a COLA at the time of import.
The American label does not replace the European one: Article 119 of Regulation (EU) 1308/2013 also applies to wine intended for export, as explained on the page about wine documents and its label. The differences between destination markets are in the export label, market by market.
FDA registration of the winery: before producing, with an agent in the United States
An Italian winery that produces wine for the United States registers with the FDA before starting. 21 CFR 1.230 requires registration before the facility manufactures, processes, packs or holds food for consumption in the United States, and 21 CFR 1.501 refers to wineries as facilities required to register because they make alcoholic beverages.
A foreign winery also designates an agent in the United States. 21 CFR 1.227 defines it as a person residing or maintaining a place of business in the United States, designated by the foreign facility, and specifies that it cannot be a mailbox, an answering machine or an answering service where no one is physically present.
The agent is the channel between the FDA and the winery, for routine communications and emergencies, and the FDA treats the agent's statements as the winery's statements. That is why the agent is chosen with the same care as the importer, and the choice is put in writing before registration.
Renewing the FDA registration: from 1 October to 31 December of even-numbered years
A winery's FDA registration is renewed every two years, between 1 October and 31 December of each even-numbered year. This is set by 21 CFR 1.230(b). In 2026 the window runs from 1 October to 31 December, and the next one opens on 1 October 2028.
Missing the window has a consequence written into the regulation. Under 21 CFR 1.241(b), if the renewal does not arrive in that period the FDA considers the registration expired and treats the facility as if it had not registered. Failing to register or renew is a prohibited act under section 301(dd) of the Federal Food, Drug, and Cosmetic Act.
«FDA will consider a registration for a food facility to be expired if the registration is not renewed» (21 CFR 1.241(b))
Wine and the FSVP: the alcoholic beverage exemption
Wine is exempt from the FSVP, the programme through which the US importer verifies foreign food suppliers. 21 CFR 1.501(e) exempts alcoholic beverages imported from a facility that must register with the FDA because it makes them, and that in the United States would need a permit or registration with the Treasury Department.
The exemption covers the wine, not everything the winery sells. Foods other than alcoholic beverages coming from the same winery, such as an oil or a jam, are exempt only if prepackaged so as to prevent contact with hands and if they do not exceed 5% of the facility's total sales. For an olive mill the obligations are different, and they are in exporting olive oil to the United States.
Prior notice: how many hours before arrival
Every wine shipment to the United States is announced to the FDA with prior notice, which the FDA must confirm before arrival. 21 CFR 1.279 sets the minimum lead time on the port of arrival: 2 hours for goods by road, 4 hours for goods by rail or air, 8 hours for goods by sea.
There is also a limit the other way. Prior notice cannot be submitted more than 30 days before arrival through the ABI/ACE customs system, or more than 15 days before through the FDA portal, the Prior Notice System Interface. The downloadable sheet works out both dates from the day and time of arrival.
| Arrival | Minimum lead time | Maximum lead time |
|---|---|---|
| By road | 2 hours | 30 days via ABI/ACE, 15 via the FDA portal |
| By rail | 4 hours | 30 days via ABI/ACE, 15 via the FDA portal |
| By air | 4 hours | 30 days via ABI/ACE, 15 via the FDA portal |
| By sea | 8 hours | 30 days via ABI/ACE, 15 via the FDA portal |
The hours are counted on the time at the port of arrival, not Italian time. Who submits prior notice, the importer or their customs broker, is agreed in writing before booking the ship: it is the one item on the list that nobody does unless it has been assigned.
The duty on wine in the United States
The US duty on Italian wine is not on this page, on purpose. It is read on the Harmonized Tariff Schedule of the United States, the HTS published by the U.S. International Trade Commission, with your own heading code and in the version of the day you make the offer. Who pays it is decided by the Incoterm written in the offer.
Who pays what, between transport, duty and customs clearance, is in Incoterms: who pays what. On the Italian side the wine leaves like any wine bound outside the EU, with the accompanying document and the EX1 export declaration.
The template, to download
One file, two sheets. The first is the checklist of steps, with the section of the regulation next to each line and a drop-down status to fill in. The second works out, from the day and time of arrival, the last useful moment for prior notice and the first day it can be submitted, and from today's date the next FDA renewal window.
| File | What it contains | Link |
|---|---|---|
| Wine in the United StatesExcel, two sheets | Sixteen checklist lines with the source, the prior notice calculation and the FDA registration renewal window. |
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, and is read on the HTS.
Questions and answers
What do you need to export wine to the United States?
A US importer with a TTB basic permit, a COLA for each label, the winery registered with the FDA with an agent in the United States, and prior notice to the FDA before every arrival. These are four steps set by the Code of Federal Regulations: 27 CFR 1.20 and 4.40 for the TTB, 21 CFR 1.230, 1.227 and 1.279 for the FDA.
On the Italian side you still need the wine's accompanying document and the export declaration. The duty is read on the US Harmonized Tariff Schedule of the day.
Who must hold the COLA, the winery or the importer?
Whoever releases the wine from customs custody, which is normally the importer. 27 CFR 4.40 states that bottled wine does not leave customs unless the person releasing it holds a COLA, and that the bottles must carry labels identical to those on the certificate.
An importer can use a COLA issued to someone else only if every bottle carries the holder's name and address and the importer can show it is authorised. The COLA covers wine from 7% alcohol by volume upwards, in retail containers.
When does a winery renew its FDA registration?
Every two years, between 1 October and 31 December of each even-numbered year, as set by 21 CFR 1.230(b). In 2026 the window runs from 1 October to 31 December, and the next one opens on 1 October 2028.
If the renewal does not arrive in that period, under 21 CFR 1.241(b) the FDA considers the registration expired and treats the facility as unregistered. Failing to register or renew is a prohibited act under section 301(dd) of the Federal Food, Drug, and Cosmetic Act.
Does wine imported into the United States have to comply with the FSVP?
No. 21 CFR 1.501(e) exempts from the FSVP, the foreign supplier verification programme, alcoholic beverages imported from a facility that must register with the FDA because it makes them, and of a kind that in the United States would need a Treasury Department permit, such as a winery.
The exemption covers the wine. Other foods from the same winery are exempt only if prepackaged and if they do not exceed 5% of the facility's total sales.
How long before arrival must prior notice be submitted?
21 CFR 1.279 sets the minimum lead time on the port of arrival: 2 hours for goods by road, 4 hours by rail or air, 8 hours by sea. Prior notice must be submitted and confirmed by the FDA by then.
It cannot be submitted too early: no more than 30 days before arrival through the ABI/ACE customs system, and no more than 15 days before through the FDA portal. The hours are counted on the time at the port of arrival.
Notes on sources
- Code of Federal Regulations, title 27, section 1.20: the basic permit for wine importers. The quotation marks enclose the text verbatim.
- Code of Federal Regulations, title 27, section 4.40, paragraph (a): the COLA, labels identical to the certificate, using someone else's COLA.
- TTB, labelling imported wine, page updated 12 January 2026: the 7% alcohol by volume threshold and bulk wine.
- Code of Federal Regulations, title 21, section 1.227: the definition of the US agent.
- Code of Federal Regulations, title 21, section 1.230: registration and renewal between 1 October and 31 December of even-numbered years.
- Code of Federal Regulations, title 21, section 1.241, paragraph (b): a registration not renewed is considered expired. The quotation marks enclose the text verbatim.
- Code of Federal Regulations, title 21, section 1.279: prior notice timing.
- Code of Federal Regulations, title 21, section 1.501, paragraph (e): the alcoholic beverage exemption from the FSVP and the 5% limit for other foods.
- The sections of the Code of Federal Regulations were read on 25 September 2026 in the annual edition updated to 1 April 2025, published on govinfo.gov. Before printing a lot it is worth reopening them in the current version.
- The duty is not given: it is read on the US Harmonized Tariff Schedule, with the heading code, on the day of the offer.
In the United States the first question goes to the importer.
Who applies for the COLA, who submits prior notice, who acts as agent. If the three answers are on a signed sheet, the rest is calendar. With Itria we start from the outside to build custom digital systems for exporters. For you that translates into more requests, fewer losses and less manual work. Write us a line about what weighs on you. We take the first step: what a buyer sees when they look you up, and what we found there. Even if we don't end up working together.