Exporting products to the United States represents a major opportunity for distributors, trading companies, and manufacturers, but it also involves strict regulatory compliance. In this blog, we explain the five key requirements for successfully exporting food products to the U.S.: FDA Facility Registration (FFRN), U.S. Agent, FDA labeling, DUNS number, and, for alcoholic beverages, TTB approval.
FDA Facility Registration (FFRN) is mandatory for any domestic or foreign company that manufactures, processes, packs, or holds food, beverages, supplements, cosmetics, or animal products intended for the U.S. market.
This registration allows the Food and Drug Administration (FDA) to track supply chains and product traceability in order to respond quickly to public health risks.
To complete the registration, you will need:
The registration must be renewed every two years, between October and December of each even-numbered year. Failure to renew on time may result in FDA suspension, product refusal at the border, or legal enforcement actions.
Are you a distributor handling third-party products?
Even if you do not manufacture the products, you may still be required to register if you handle storage or logistics. Reviewing your supply chain carefully is critical to determine your obligations.
The FDA requires all foreign registered facilities to designate a U.S. Agent. This agent acts as the official liaison between your company and the FDA by receiving regulatory notifications, coordinating inspections, and responding to emergencies.
Designating a friend or relative in the U.S. may seem convenient, but it carries significant risk. Poor handling of FDA communications can lead to border holds, market withdrawals, or legal consequences.
Working with a professional and specialized U.S. Agent, such as the CORE team, ensures that your regulatory obligations are handled promptly, accurately, and with technical expertise.
Important: the U.S. Agent must have a physical address, not a P.O. box, and must be available to respond immediately to FDA inquiries.
Labeling is one of the most closely monitored aspects by both the FDA and U.S. Customs. Errors in design, language, or content can stop your product at the border, even if your registration is valid.
FDA-compliant labels must include:
Labels must also be clear, legible, and accurate. Many distributors lose opportunities by relying on generic or unvalidated labels, which may trigger FDA Import Alerts for the product, company, or even the country of origin.
The DUNS (Data Universal Numbering System) number is a unique nine-digit identifier issued by Dun & Bradstreet. It is required to complete FDA facility registration and serves to verify your companyâs legal existence in international databases.
Why is the DUNS number essential?
Although obtaining a DUNS number is free, proper management is essential to ensure your company information is accurate and aligned with your actual operations.
If you export or import alcoholic beverages, you must also comply with regulations issued by the Alcohol and Tobacco Tax and Trade Bureau (TTB), which oversees the production, labeling, and distribution of alcohol in the U.S.
Key requirements include:
Errors in formulas or labels are among the most common causes of customs rejection, which is why many distributors seek regulatory review during the product design phase.
Failing to comply with FDA or TTB requirements can result in serious consequences, including:
In short, compliance is not optional, it is an investment that protects your business and positions you as a reliable international partner.
Exporting to the United States is challenging, but with the right guidance, it can become a sustainable and profitable growth strategy. From FFRN registration and U.S. Agent designation to FDA labeling validation, DUNS management, and TTB compliance, every step matters.
At CORE Consulting, our team specializes in FDA, TTB, and international regulatory compliance. We help you avoid costly mistakes, meet regulatory standards, and streamline your entry into the U.S. market.
Ready to export to the United States with confidence?
Schedule a consultation with our experts and take the first step, securely and strategically.
Exporting products to the United States represents a major opportunity for distributors, trading companies, and manufacturers, but it also involves strict regulatory compliance. In this blog, we explain the five key requirements for successfully exporting food products to the U.S.: FDA Facility Registration (FFRN), U.S. Agent, FDA labeling, DUNS number, and, for alcoholic beverages, TTB approval.
FDA Facility Registration (FFRN) is mandatory for any domestic or foreign company that manufactures, processes, packs, or holds food, beverages, supplements, cosmetics, or animal products intended for the U.S. market.
This registration allows the Food and Drug Administration (FDA) to track supply chains and product traceability in order to respond quickly to public health risks.
To complete the registration, you will need:
The registration must be renewed every two years, between October and December of each even-numbered year. Failure to renew on time may result in FDA suspension, product refusal at the border, or legal enforcement actions.
Are you a distributor handling third-party products?
Even if you do not manufacture the products, you may still be required to register if you handle storage or logistics. Reviewing your supply chain carefully is critical to determine your obligations.
The FDA requires all foreign registered facilities to designate a U.S. Agent. This agent acts as the official liaison between your company and the FDA by receiving regulatory notifications, coordinating inspections, and responding to emergencies.
Designating a friend or relative in the U.S. may seem convenient, but it carries significant risk. Poor handling of FDA communications can lead to border holds, market withdrawals, or legal consequences.
Working with a professional and specialized U.S. Agent, such as the CORE team, ensures that your regulatory obligations are handled promptly, accurately, and with technical expertise.
Important: the U.S. Agent must have a physical address, not a P.O. box, and must be available to respond immediately to FDA inquiries.
Labeling is one of the most closely monitored aspects by both the FDA and U.S. Customs. Errors in design, language, or content can stop your product at the border, even if your registration is valid.
FDA-compliant labels must include:
Labels must also be clear, legible, and accurate. Many distributors lose opportunities by relying on generic or unvalidated labels, which may trigger FDA Import Alerts for the product, company, or even the country of origin.
The DUNS (Data Universal Numbering System) number is a unique nine-digit identifier issued by Dun & Bradstreet. It is required to complete FDA facility registration and serves to verify your companyâs legal existence in international databases.
Why is the DUNS number essential?
Although obtaining a DUNS number is free, proper management is essential to ensure your company information is accurate and aligned with your actual operations.
If you export or import alcoholic beverages, you must also comply with regulations issued by the Alcohol and Tobacco Tax and Trade Bureau (TTB), which oversees the production, labeling, and distribution of alcohol in the U.S.
Key requirements include:
Errors in formulas or labels are among the most common causes of customs rejection, which is why many distributors seek regulatory review during the product design phase.
Failing to comply with FDA or TTB requirements can result in serious consequences, including:
In short, compliance is not optional, it is an investment that protects your business and positions you as a reliable international partner.
Exporting to the United States is challenging, but with the right guidance, it can become a sustainable and profitable growth strategy. From FFRN registration and U.S. Agent designation to FDA labeling validation, DUNS management, and TTB compliance, every step matters.
At CORE Consulting, our team specializes in FDA, TTB, and international regulatory compliance. We help you avoid costly mistakes, meet regulatory standards, and streamline your entry into the U.S. market.
Ready to export to the United States with confidence?
Schedule a consultation with our experts and take the first step, securely and strategically.
