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 the importer 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 anyone from carrying on the business of importing wine into the United States without a federal permit. So for an Italian winery the first step is choosing the importer: the permit is theirs, and the label and customs clearance are tied to them.
The label is approved before it's printed. Under 27 CFR 4.40, bottled wine can't be released from customs custody unless the person releasing it holds a certificate of label approval, the COLA, and 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. If a registration isn't renewed, the FDA considers it expired.
This page is part of exporting wine: the documents, who issues them and when you need them, and covers a single market, the United States. What wine shares with every shipment leaving the EU, such as the invoice, packing list and export declaration, is in the documents that go with a shipment.
How to export wine to the United States: the four steps
Exporting wine to the United States takes four steps, in the order they come up: an importer with a TTB basic permit, a COLA for every label, the winery registered with the FDA with a US agent, and prior notice to the FDA before every arrival. Duty comes on top, and you look it up 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 nobody can import wine to trade in it. |
| COLA for every labelTTB | The party that takes the wine out of customs, normally the importer. |
27 CFR 4.40: without a COLA, bottled wine stays in customs custody. |
| Winery registrationFDA, with a US agent | The Italian winery, before it produces for that market. |
21 CFR 1.230 and 1.227: renewal in even-numbered years, an agent physically present. |
| Prior notice for every 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 holders of a basic permit issued by the TTB can import wine. The TTB is the Treasury Department bureau that regulates alcoholic beverages. 27 CFR 1.20 says that nobody, except under that permit, may carry on the business of importing wine, or sell or ship wine imported that way.
“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 practical consequence is clear: the first negotiation is with an importer who already has the permit. They take the wine out of customs, and the law ties the label certificate to the party that does that. That's why changing importer after the first order costs more than choosing well at the start.
What a wine COLA is, and who needs one
The COLA is the certificate of label approval issued by the TTB, and without one bottled wine stays in customs. 27 CFR 4.40 puts it like this: wine imported in containers can't 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 expensive one: the bottles must carry labels identical to those shown on the certificate, or with only the changes the form allows. You get the label approved, then you print the run. A run printed before approval, with one detail different, is a run that won't get through.
The certificate belongs to the person who applied for it. If an importer uses a COLA issued to someone else, every bottle must carry the COLA holder's name and address, and the importer must be able to show it's authorised to use it. So anyone changing importer needs to know beforehand who owns the certificate for their labels.
The COLA applies to wine at 7% alcohol by volume or more, imported in retail containers: the TTB says so on its page about labelling imported wine, updated on 12 January 2026. Bulk wine, in containers not meant for retail sale, doesn't need a COLA at the time of import.
The American label doesn't replace the European one: Article 119 of Regulation (EU) 1308/2013 also applies to wine destined for export, as explained on the page about the documents for wine and its label. The differences between destination markets are in export labelling, market by market.
The winery's FDA registration: before production, with a US agent
An Italian winery producing wine for the United States registers with the FDA before it starts. 21 CFR 1.230 requires registration before a facility makes, 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 names a US agent. 21 CFR 1.227 defines this as a person who lives or has a place of business in the United States, designated by the foreign facility, and specifies that it can't be a mailbox, an answering machine or an answering service where nobody 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 own. So you choose the agent as carefully as the importer, and the choice goes in writing before registration.
Renewing the FDA registration: 1 October to 31 December in even-numbered years
A winery's FDA registration is renewed every two years, between 1 October and 31 December of each even-numbered year. That's set out in 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 regulations. Under 21 CFR 1.241(b), if the renewal doesn't arrive in that period the FDA considers the registration expired and treats the facility as if it had never 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 US importers use to verify foreign food suppliers. 21 CFR 1.501(e) exempts alcoholic beverages imported from a facility required to register with the FDA because it makes them, and that would need a permit or registration with the Treasury Department in the United States.
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 they're prepackaged so as to prevent contact by hand and make up no more than 5% of the facility's total sales. An olive mill has different obligations, covered in exporting olive oil to the United States.
Prior notice: how many hours before arrival
Every shipment of wine to the United States is announced to the FDA with a prior notice, which the FDA must confirm before arrival. 21 CFR 1.279 sets the minimum lead time before arrival at the port: 2 hours for goods by road, 4 hours for goods by rail or air, 8 hours for goods by sea.
There's a limit in the other direction too. Prior notice can't 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 in the time zone of the port of arrival, not Italian time. Who submits the prior notice, the importer or their customs broker, is agreed in writing before the ship is booked: it's the one item on the list that nobody does unless it's been assigned.
US duty on wine
The US duty on Italian wine 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 the version in force on the day you make the offer. Who pays it depends on the Incoterm written in the offer.
Who pays for what, across freight, duty and customs clearance, is in Incoterms: who pays for what. On the Italian side, the wine leaves like any wine heading outside the EU, with its accompanying document and the EX-1 export declaration.
The template, to download
One file, two sheets. The first is the checklist of steps, with the section of the regulations next to each line and a drop-down status to fill in. The second works out, from the day and time of arrival, the latest moment for prior notice and the first day you can submit it, and from today's date the next FDA renewal window.
| File | Contents | Link |
|---|---|---|
| Wine to the United StatesExcel, two sheets | Sixteen checklist lines with their sources, the prior notice calculation and the FDA registration renewal window. |
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, and you look it up in the HTS.
Questions and answers
What do you need to export wine to the United States?
A US importer holding a TTB basic permit, a COLA for every label, the winery registered with the FDA with a US agent, and prior notice to the FDA before every arrival. These four steps are 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 on the current US Harmonized Tariff Schedule.
Who needs the COLA, the winery or the importer?
The party that takes the wine out of customs custody, which is normally the importer. 27 CFR 4.40 says bottled wine can't be released from 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 at 7% alcohol by volume or more, 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 out in 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 doesn't come 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 Program, alcoholic beverages imported from a facility required to register with the FDA because it makes them, and of a kind that would need a Treasury Department permit in the United States, such as a winery.
The exemption covers wine. Other foods from the same winery are exempt only if they're prepackaged and make up no more than 5% of the facility's total sales.
How long before arrival does prior notice have to be submitted?
21 CFR 1.279 sets the minimum lead time before arrival at the port: 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 can't be submitted too early either: 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 in the time zone of the port of arrival.
Notes on sources
- Code of Federal Regulations, Title 27, section 1.20: the basic permit for wine importers. The quotation is word for word.
- 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 on 12 January 2026: the 7% alcohol by volume threshold and bulk wine.
- Code of Federal Regulations, Title 21, section 1.227: the definition of a US agent.
- Code of Federal Regulations, Title 21, section 1.230: registration and renewal between 1 October and 31 December in even-numbered years.
- Code of Federal Regulations, Title 21, section 1.241, paragraph (b): a registration not renewed is considered expired. The quotation is word for word.
- Code of Federal Regulations, Title 21, section 1.279: prior notice timing.
- Code of Federal Regulations, Title 21, section 1.501, paragraph (e): the FSVP exemption for alcoholic beverages 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 revised as of 1 April 2025, published on govinfo.gov. Before printing a run, open them again in the current version.
- Duty isn't given here: you look it up in the US Harmonized Tariff Schedule, using the product 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 the prior notice, who acts as agent. If the three answers are on a signed sheet, the rest is a calendar. At Itria we start from the outside and build tailored digital systems for exporters. For you, that means more enquiries, fewer losses and less manual work. Drop us a line about what's slowing you down. We'll make the first move: we'll look at what a buyer sees when they search for you, and tell you what we found. Even if we never end up working together.