Requirements to export and import alcoholic beverages to the United States: a compliance guide with FDA, TTB, and more

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January 28, 2026
TTB FDA

Exporting or importing alcoholic beverages into the U.S. market represents a significant growth opportunity for manufacturers, producers, private-label brands, distributors, and trading companies. However, having a competitive product is not enough. To legally enter the United States and avoid detentions, penalties, or commercial losses, you must comply with mandatory regulatory requirements enforced by the FDA (Food and Drug Administration) and the TTB (Alcohol and Tobacco Tax and Trade Bureau).

In this guide, we explain the five essential compliance services you must consider before exporting or importing alcoholic beverages into the United States.

Who must comply with these requirements?

Regulatory requirements apply to both exporters and importers, regardless of whether you sell wine, beer, spirits, ready-to-drink cocktails (RTDs), or emerging categories such as functional alcoholic beverages.

Whether you manufacture, commercialize, store, or distribute alcoholic beverages, you are required to comply with health, tax, and labeling regulations to legally enter the U.S. market.

Important: Failure to comply may result in customs holds, fines, additional inspections, or even the termination of commercial relationships.

1. DUNS Number

The DUNS (Data Universal Numbering System) is a unique nine-digit international identification number issued by Dun & Bradstreet.

Both the FDA and the TTB require this number to legally identify each facility or company participating in the supply chain.

If your company bottles, stores, or exports alcoholic beverages to the U.S., you must obtain a DUNS number to:

  • Register your establishment with the FDA and TTB
  • Participate in programs such as FSVP (for importers)
  • Be recognized as a valid and reliable entity in government databases

Having a DUNS number is not only mandatory—it also strengthens your credibility and commercial traceability.

Need help obtaining your DUNS number? Contact us.

2. FFRN Registration

The FFRN (Food Facility Registration Number) is mandatory for any facility that manufactures, processes, packs, or holds food or beverages for consumption in the United States, including alcoholic beverages.

This registration must be:

  • Completed directly through the FDA platform
  • Renewed every even-numbered year (biennial renewal)
  • Supported by a valid DUNS number and a U.S. FDA Agent for foreign facilities

A common misconception is that alcoholic beverages do not require FDA registration because they are regulated by the TTB. In reality, both agencies share regulatory authority, and the FFRN remains mandatory because alcoholic beverages are considered food under FDA regulations.

We support you in registering your facilities and keeping your FFRN active and compliant. Request advisory support here.

3. FDA U.S. Agent

If your company is located outside the United States, you must designate a U.S. FDA Agent.

This representative:

  • Acts as the official point of contact between your company and the FDA
  • Receives notifications, alerts, and inspection requests
  • Must have a physical presence and immediate availability in the U.S.
  • Cannot be a P.O. box or an untrained individual

Appointing a friend or acquaintance as your FDA Agent can be costly. An unqualified agent may cause serious compliance errors that result in product detentions, penalties, or audits. Choosing a professional and experienced FDA Agent is critical to protecting your operations.

Don’t have a U.S. Agent? CORE can represent you. Learn how we can help.

4. FDA Labeling

Labeling is one of the most closely scrutinized aspects of exporting or importing alcoholic beverages. While many labels are reviewed by the TTB, the FDA also regulates health-related information, ingredients, and warnings for certain products.

To avoid customs holds, import alerts, or costly relabeling, your label must comply with:

  • Product name (in English and aligned with TTB standards)
  • Ingredient list in descending order by weight
  • Manufacturer or responsible party information
  • Required legal statements or health warnings
  • Nutrition labeling (when applicable)

Before printing thousands of labels, make sure they are validated against current regulations.

Does your label comply with FDA requirements? Request a label review.

5. TTB Compliance

The Alcohol and Tobacco Tax and Trade Bureau (TTB) is the U.S. Treasury agency responsible for regulating taxes, permits, formulas, and labeling of alcoholic beverages.

To export alcoholic beverages to the United States, you must comply with:

  • Company registration as a producer, bottler, or importer
  • Obtaining a Federal Basic Permit
  • Submitting formula approvals (when required)
  • Obtaining COLA (Certificate of Label Approval) prior to commercialization

TTB compliance is closely linked to tax traceability and may involve audits, penalties, or restrictions if reporting is inaccurate or incomplete.

We guide you step by step through the TTB permitting process. Contact us today.

What happens if you do not meet these requirements?

Exporting without a DUNS number, without proper facility registration, or with non-compliant labels may result in:

  • Shipment detention at customs
  • Increased operational costs due to last-minute corrections
  • Product rejection by importers or distributors
  • Administrative penalties or loss of FDA or TTB permits

Do not let avoidable errors jeopardize your operation.

How can CORE Solutions help you?

At CORE Solutions, we specialize in regulatory compliance for exporters and importers of alcoholic beverages. We support you at every stage of the compliance process—whether you are exporting or importing.

Schedule a personalized consultation today and start exporting to the United States without risks or delays. Contact us today.

Requirements to export and import alcoholic beverages to the United States: a compliance guide with FDA, TTB, and more

.
January 28, 2026
TTB FDA

Exporting or importing alcoholic beverages into the U.S. market represents a significant growth opportunity for manufacturers, producers, private-label brands, distributors, and trading companies. However, having a competitive product is not enough. To legally enter the United States and avoid detentions, penalties, or commercial losses, you must comply with mandatory regulatory requirements enforced by the FDA (Food and Drug Administration) and the TTB (Alcohol and Tobacco Tax and Trade Bureau).

In this guide, we explain the five essential compliance services you must consider before exporting or importing alcoholic beverages into the United States.

Who must comply with these requirements?

Regulatory requirements apply to both exporters and importers, regardless of whether you sell wine, beer, spirits, ready-to-drink cocktails (RTDs), or emerging categories such as functional alcoholic beverages.

Whether you manufacture, commercialize, store, or distribute alcoholic beverages, you are required to comply with health, tax, and labeling regulations to legally enter the U.S. market.

Important: Failure to comply may result in customs holds, fines, additional inspections, or even the termination of commercial relationships.

1. DUNS Number

The DUNS (Data Universal Numbering System) is a unique nine-digit international identification number issued by Dun & Bradstreet.

Both the FDA and the TTB require this number to legally identify each facility or company participating in the supply chain.

If your company bottles, stores, or exports alcoholic beverages to the U.S., you must obtain a DUNS number to:

  • Register your establishment with the FDA and TTB
  • Participate in programs such as FSVP (for importers)
  • Be recognized as a valid and reliable entity in government databases

Having a DUNS number is not only mandatory—it also strengthens your credibility and commercial traceability.

Need help obtaining your DUNS number? Contact us.

2. FFRN Registration

The FFRN (Food Facility Registration Number) is mandatory for any facility that manufactures, processes, packs, or holds food or beverages for consumption in the United States, including alcoholic beverages.

This registration must be:

  • Completed directly through the FDA platform
  • Renewed every even-numbered year (biennial renewal)
  • Supported by a valid DUNS number and a U.S. FDA Agent for foreign facilities

A common misconception is that alcoholic beverages do not require FDA registration because they are regulated by the TTB. In reality, both agencies share regulatory authority, and the FFRN remains mandatory because alcoholic beverages are considered food under FDA regulations.

We support you in registering your facilities and keeping your FFRN active and compliant. Request advisory support here.

3. FDA U.S. Agent

If your company is located outside the United States, you must designate a U.S. FDA Agent.

This representative:

  • Acts as the official point of contact between your company and the FDA
  • Receives notifications, alerts, and inspection requests
  • Must have a physical presence and immediate availability in the U.S.
  • Cannot be a P.O. box or an untrained individual

Appointing a friend or acquaintance as your FDA Agent can be costly. An unqualified agent may cause serious compliance errors that result in product detentions, penalties, or audits. Choosing a professional and experienced FDA Agent is critical to protecting your operations.

Don’t have a U.S. Agent? CORE can represent you. Learn how we can help.

4. FDA Labeling

Labeling is one of the most closely scrutinized aspects of exporting or importing alcoholic beverages. While many labels are reviewed by the TTB, the FDA also regulates health-related information, ingredients, and warnings for certain products.

To avoid customs holds, import alerts, or costly relabeling, your label must comply with:

  • Product name (in English and aligned with TTB standards)
  • Ingredient list in descending order by weight
  • Manufacturer or responsible party information
  • Required legal statements or health warnings
  • Nutrition labeling (when applicable)

Before printing thousands of labels, make sure they are validated against current regulations.

Does your label comply with FDA requirements? Request a label review.

5. TTB Compliance

The Alcohol and Tobacco Tax and Trade Bureau (TTB) is the U.S. Treasury agency responsible for regulating taxes, permits, formulas, and labeling of alcoholic beverages.

To export alcoholic beverages to the United States, you must comply with:

  • Company registration as a producer, bottler, or importer
  • Obtaining a Federal Basic Permit
  • Submitting formula approvals (when required)
  • Obtaining COLA (Certificate of Label Approval) prior to commercialization

TTB compliance is closely linked to tax traceability and may involve audits, penalties, or restrictions if reporting is inaccurate or incomplete.

We guide you step by step through the TTB permitting process. Contact us today.

What happens if you do not meet these requirements?

Exporting without a DUNS number, without proper facility registration, or with non-compliant labels may result in:

  • Shipment detention at customs
  • Increased operational costs due to last-minute corrections
  • Product rejection by importers or distributors
  • Administrative penalties or loss of FDA or TTB permits

Do not let avoidable errors jeopardize your operation.

How can CORE Solutions help you?

At CORE Solutions, we specialize in regulatory compliance for exporters and importers of alcoholic beverages. We support you at every stage of the compliance process—whether you are exporting or importing.

Schedule a personalized consultation today and start exporting to the United States without risks or delays. Contact us today.

Do you still have questions after reading the article?

Contact our specialists today and ensure the success of your import or export process—avoiding costly mistakes, delays, and compliance issues.
Learn more

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