International Trade and Regulatory Support for Food Exporters

Who this is for

Food and beverage producers in Europe preparing their first shipment to the United States, or adding a new product category.

US importers and distributors who need their foreign suppliers to meet US requirements before they sign an order.

Brands with a contract manufacturer who want to be sure that the facility, the label and the importer roles are set up correctly.

What we do

FDA Coordination

We prepare and coordinate your food facility registration, including the DUNS number, the US agent and the FDA Industry Systems account, and we manage the renewal that is due every two years. The current renewal window closes on 31 December 2026. We also help you respond to FDA requests and keep your records in order.

FSMA Guidance

The Food Safety Modernization Act shapes what US importers expect from you: a food safety plan, hazard analysis, allergen controls and supplier records. We explain which requirements apply to your facility and product, help you prepare the documents importers ask for, and prepare you for an importer's verification under the Foreign Supplier Verification Program.

Import Documentation

We prepare and check the documents for each shipment: commercial invoice, packing list, certificate of origin, specification sheets, and health or phytosanitary certificates where they apply. We make sure they match each other, because customs systems compare them.

Customs Coordination

We work with your customs broker and importer on tariff classification, duty and the entry process, so that the Harmonized System code on your invoice is correct and the landed cost in your quote is realistic.

Label Compliance

US and EU labels differ on nutrition panels, units, allergens, claims and language. We review your labels against US rules, brief your designer on what to change, and check the final artwork before it goes to print.

International Shipping Support

We help you plan the route and the timing, coordinate Prior Notice with your importer or broker, and prepare for cold chain and handling requirements so that a compliant product also arrives in good condition.

Regulatory Planning

Before you commit to a buyer, we map the rules for your exact product and destination, list what has to be done, in what order and by whom, and give you a realistic timeline.

Common problems we help solve

• A facility registration that has expired, or a DUNS number whose address does not match the registration.

• No US agent, or an agent who does not respond.

• A US label copied from a European one, with missing allergens or the wrong units.

• An importer who asks for a food safety plan and audit report that you do not yet have in the right form.

• Prior Notice filed late or with details that do not match the shipment.

• Uncertainty about who is the importer, who files what and who carries which responsibility.

How we work

1. Discover. We review your product, facility, labels and markets, and what you already have in place.

2. Design. We map the requirements and build a clear plan with owners and dates.

3. Source. We bring in the partners you need, such as a US agent, a customs broker or a label designer.

4. Launch. We coordinate the first shipment, from registration and documents to Prior Notice and delivery.

5. Scale. We keep your registration, documents and labels up to date as you add products and markets.

Guides that explain the rules

• FDA food facility registration for foreign producers

• How to choose an FDA US agent

• FDA Prior Notice explained

• FSVP explained for European producers

• US versus EU food labels

• Food export compliance between the US and Europe: a practical checklist

Frequently asked questions

Do I need to register my facility with the FDA to sell food in the US?

If your facility manufactures, processes, packs or holds food for US consumption, yes. A foreign facility must also name a US agent. Registration is free and must be renewed every two years, between 1 October and 31 December of even numbered years.

What is Prior Notice and who files it?

Prior Notice is an advance notification to the FDA about each shipment of food arriving in the US. It is usually filed by your importer, customs broker or another party you designate, and it must match the facility registration and the shipment.

Who is the FSVP importer?

Under the Foreign Supplier Verification Program, the importer is generally the US owner or consignee of the food at the time of entry. That importer must verify that you produce food to US safety standards, and will ask you for documents to prove it.

Will my European label work in the US?

Almost never without changes. The US requires a Nutrition Facts panel in its own format, US units, nine major allergens including sesame, and specific wording for the name of the business responsible for the product.

Can you file things on my behalf?

We prepare and coordinate registrations, documents and filings with you, your importer and your customs broker. Some steps, such as an importer's FSVP programme or a customs entry, must be carried out by the party that is legally responsible, and we will tell you who that is.

Is this legal advice?

No. We provide practical regulatory support for food trade. For legal questions about your specific situation, we recommend confirming with a qualified lawyer or the relevant authority.