Legal Counsel for Foreign Food Producers and U.S. Importers

Selling food or beverages in the United States means meeting FDA, USDA, and state requirements that can differ sharply from those at home. A label that is lawful abroad may be non-compliant here, and a shipment held at the port can stop a launch.

MDRXLaw helps foreign producers and the U.S. importers who bring their products in to enter the market correctly, respond quickly when shipments are stopped, and protect their brands once products are on the shelf.

Entering the U.S. Market

We guide foreign producers and importers through the steps required before a product ships:

• FDA facility registration, including the required U.S. agent, and timely renewals.

• Foreign Supplier Verification Program (FSVP) plans and recordkeeping for importers, and

  prior notice filings.

• U.S. labeling review, covering nutrition facts, allergens, ingredient names, serving sizes, and claims, so that foreign packaging does not delay entry.

• Product-specific rules, including USDA requirements for meat, poultry, and eggs, plant-product restrictions, and TTB permits and label approvals for alcoholic beverages.

• Traceability and supplier documentation to meet FDA recordkeeping expectations.

When a Shipment Is Stopped

A detention or import alert can leave perishable product sitting at the port and a customer waiting. Time matters, so we act quickly to:

• Respond to FDA detentions and refusals, and develop evidence and arguments to release product.

• Petition to remove a product, producer, or shipper from an import alert.

• Respond to FDA warning letters and requests for corrective action.

• Manage recalls and market withdrawals, including communications with FDA and customers.

• Defend related consumer and regulatory claims in the U.S. (see our Consumer & Regulatory Defense practice).

Protecting Your Brand and Your U.S. Business

A product that clears customs still needs a protected brand and sound contracts. We help clients with:

• U.S. trademark registration for foreign brands. Applicants based outside the U.S. must be represented by a U.S.-licensed attorney.

• Importer, distributor, and supply agreements, including exclusivity, termination, indemnity, insurance, and recall responsibilities.

• Grey market and parallel import disputes, including unauthorized sales of genuine branded goods.

• Advertising and marketing review for the U.S. market.

Why MDRXLaw

Our New York office combines regulatory and litigation experience, so one team can prepare your market entry and defend it if a shipment, label, or claim is challenged. We work with laboratories and consultants where a matter needs them, and we explain U.S. requirements in plain terms for clients who are new to the market.

Frequently Asked Questions

Does a foreign food facility need to register with FDA?

Generally yes. Foreign facilities that manufacture, process, pack, or hold food for U.S. consumption must register with FDA and name a U.S. agent. Registration must be renewed on a set schedule, and some products are exempt or covered by other agencies.

What is an FSVP?

The Foreign Supplier Verification Program requires many U.S. importers to verify that their foreign suppliers produce food that meets U.S. safety standards. Importers need a written plan and records.

Why was my shipment detained?

Common reasons include label problems, undeclared allergens, contamination findings, unapproved ingredients, or a listing on an FDA import alert. The right response depends on the stated reason, so send us the notice right away.

Can a foreign company register a U.S. trademark?

Yes. A foreign-based applicant must use a U.S.-licensed attorney for the application.

Talk to Us

If you plan to export food to the United States, import it, or have received a detention, refusal, or warning letter, contact us for a confidential consultation.