According to the U.S. Food and Drug Administration (FDA) regulations, all facilities that manufacture, process, pack, or store food, beverages, and dietary supplements intended for sale in the United States must be registered with the FDA. To complete the registration, companies based outside of the U.S. must have a U.S. agent who will act as the primary contact with the FDA on behalf of the foreign company.

The U.S. agent may be required to communicate with the FDA regarding registration. This can be a time-sensitive issue. Therefore, the U.S. agent must be knowledgeable about FDA regulations and capable of advising the foreign company on the FDA requirements that must be met. Additionally, having an independent U.S. agent helps prevent potential conflicts of interest, which could arise if a business partner is designated as the U.S. agent.

The U.S. FDA requires that prior notice be submitted to the FDA before food shipments enter the United States. We will assist companies in obtaining a confirmation number, which will be used by U.S. customs brokers for clearing the goods