Exporting Wine to the United States

Regulatory Overview and Market Entry Guidance

Important Notice

This document is provided for general informational purposes only. It does not constitute legal, tax, customs, or regulatory advice, and should not be relied upon as such.

The content is intended to support educational and planning purposes only. Wineries and exporters are solely responsible for complying with all applicable laws and regulations in the United States and any other jurisdictions.

Before taking any action regarding market entry, shipment, distribution, or commercial activities, readers should seek independent legal advice.

Use of this document does not create any professional or advisory relationship with Wine Australia, Austrade, or any affiliated parties.

This resource has been prepared to support wineries evaluating or entering the United States market.

The United States Market

The United States is the world’s largest wine market and is ranked the most attractive global wine market by industry research, including assessments conducted by Wine Intelligence. Contributing factors include:

• Premiumisation trends

• Market accessibility and relative affordability

• Forecast growth potential

• Wealth indicators

• Moderation metrics

At the same time, the United States is among the most complex alcohol regulatory environments globally.

Approximately 75% of wine consumed in the United States is domestically produced. All alcohol beverages are subject to layered federal and state regulation, with compliance obligations applying at multiple levels.

Wineries considering export should be prepared to navigate regulatory requirements including:

• Registration with the U.S. Food & Drug Administration (FDA)

• Approvals from the Alcohol and Tobacco Tax and Trade Bureau (TTB)

• Certificate of Label Approval (COLA) or COLA Waiver requirements

• State-specific commercial and licensing laws

For additional guidance, wineries may contact the North America team at:

usa@wineaustralia.com

The US Three-Tier Distribution System

Following the repeal of Prohibition in 1933, the United States established a three-tier regulatory framework for alcohol distribution. The system is designed to:

• Protect product integrity and public safety

• Ensure tax collection

• Prevent vertical market control

• Reduce anti-competitive practices

The three tiers are:

• Supplier – the exporting winery

• Importer / Distributor – the licensed entity responsible for importation and, in some cases, distribution

• Retailer – the licensed outlet selling to consumers

Critical Requirement

All foreign suppliers must appoint a licensed US-based importer in order to ship wine into the United States and sell to a distributor.

In certain states, an importer may also hold a distributor licence. However, in most states, a single entity may not operate across multiple tiers. Each tier is licensed and regulated independently.

Additionally, each US state enforces its own alcohol laws. Requirements in states such as Connecticut may differ materially from those in California. Wineries must evaluate regulatory obligations on a state-by-state basis.

Importer Structures in the United States

All imported wine must enter the US market through a licensed importer. Importers generally operate under one of two primary models:

1. Traditional Importer

Under this structure, the importer purchases the wine and serves as the winery’s official US market representative.

Typical responsibilities may include:

• Placing purchase orders with the winery

• Reviewing and coordinating label compliance

• Submitting labels to the TTB for Certificate of Label Approval (COLA)

• Storing wine in a licensed bonded warehouse

• Managing distributor relationships

• Presenting wines to retailers

• Processing retailer orders

• Submitting wines to US media

• Participating in trade and consumer events

This model provides integrated sales representation and market development support.

2. Clearing Importer

Clearing importers are licensed to:

• Import product

• Store inventory

• Deliver shipments

• Submit label approvals

However, they typically do not employ sales teams and do not actively promote or sell the wine.

Clearing importers generally charge service-based fees for:

• Receiving inventory

• Storage

• Order fulfilment

Payment to the winery typically occurs only once a distributor or retailer purchases the wine.

This structure may suit wineries with independent US sales representation or confirmed retail placements.

Direct-to-Retail Exclusive Programs

Certain large US retailers may offer exclusive-label programs. These arrangements are permitted under US law, provided:

The wine is imported through a licensed importer

The product is delivered via a licensed distributor

Exclusivity may enable retailers to improve margin and differentiate their offering.

Order volumes under such programs may range from hundreds to thousands of cases, depending on retailer scale.

Shipping Samples to the United States

Shipping wine samples into the United States is highly regulated.

Each bottle must be properly declared and accounted for through TTB and FDA processes.

Despite administrative complexity, maintaining samples in the US market is often critical to securing importer or retail partnerships.

The most efficient pathway is generally to coordinate sample shipments through a licensed US importer.

Sample Shipment Compliance Checklist

1. Certificate of Label Approval (COLA) Waiver

Before shipping non-commercial samples, a winery must obtain a COLA Waiver through its importer.

A COLA Waiver is a temporary, single-use TTB-issued authorisation permitting domestically labelled wine to enter the US for non-commercial purposes such as:

• Customer sampling

• Trade show tastings

• Educational events

These wines may not be sold commercially.

Information Required for COLA Waiver Submission:

• Company name

• Winery name

• SKU description

• Vintage

• Alcohol by volume (ABV %)

• Number of bottles

• Bottle size

• Wine type (white, red, rosé)

• Wine style (still, sparkling, fortified, dessert)

• FDA Facility Registration Number

Industry guidance commonly recommends requesting up to 12 bottles per SKU. Fewer bottles may be shipped, but the approved quantity may not be exceeded without filing a new waiver.

The importer submits the waiver application to the TTB for approval.

2. FDA Registration and Prior Notice

FDA Facility Registration

All food and beverage facilities exporting to the US must register with the FDA under:

• The Bioterrorism Act

• The Food Safety Modernization Act (FSMA)

FDA registration must be renewed every two years during even-numbered years between 1 October and 31 December.

Failure to maintain registration may result in:

• Shipment detention

• Demurrage charges

• Refusal of entry

Important: The bottling facility, not merely the brand owner, must hold the FDA registration.

Third-party providers may manage FDA registration filings for a fee.

Prior Notice Submission

A Prior Notice must be electronically filed with the FDA prior to shipment departure.

Without a valid Prior Notice:

• Shipments may be held

• Returned

• Destroyed

The US government does not reimburse losses resulting from failure to file Prior Notice.

Upon arrival, shipments are reviewed by both US Customs and the FDA. All documentation must be coordinated carefully with the courier and importer to ensure clearance.

3. Commercial Invoice Requirements

Each shipment must include a commercial invoice stating:

• Importer of Record

• Brand name

• Product type

• Alcohol percentage

• Bottle size

• Bottles per case

• Declared commercial value

US Customs will not accept a declared value of $0.

The winery remains responsible for applicable import duties and taxes.

Packing and Labelling Requirements for Samples

Before dispatch:

• Apply a Government Warning statement and “Samples Only” sticker to each bottle

• Do not obscure existing label information

Attach the following documentation externally to each case:

• Commercial invoice

• Packing list (values must match invoice)

• Approved COLA Waiver

• -Prior Notice confirmation

• Bill of lading or airway bill

Given long transit distances and potential temperature extremes, samples should be securely packed and insulated.

Allow a minimum of one week for delivery and clearance into the US.

Business Matching and Market Support

Australian Wine Connect

Wineries seeking US distribution are encouraged to complete a profile on Australian Wine Connect, a business-matching platform promoted to US importers and trade buyers.

Brand profiles should include:

• Indicative US pricing
• Brand positioning and differentiators

• Quality imagery

• Varietal portfolio

• A monitored contact email

Select the designation “Seeking distribution in the USA” to enable importer search filtering.

Profiles may be updated at any time.

Austrade Advisory Support

For additional importer introductions or broader market assistance, wineries may contact:

Austrade Advisory Team

Tel: 13 28 78

General Enquiry Form – Austrade

Austrade can connect wineries with:

• Global Engagement Managers (GEMs)

• Tradestart Advisors

• International Post representatives

Regulatory Disclaimer

This document is provided for general informational purposes only and does not constitute legal, tax, customs, or regulatory advice.

United States alcohol beverage laws are complex and subject to change at the federal, state, and local levels. Requirements vary by jurisdiction, product classification, and commercial structure.

Wineries and exporters remain solely responsible for ensuring full compliance with all applicable laws, including FDA registration, TTB approvals, Prior Notice submissions, state-level licensing, reporting requirements, and excise tax obligations.

Independent advice from qualified legal, regulatory, customs, and tax professionals should be obtained prior to shipment or market entry.

No representation, warranty, or guarantee is made regarding regulatory approval, admissibility, market access, timing, or commercial outcomes.