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FDA Announces Establishment of U.S. Agent Voluntary Identification System

In guidance issued on October 16, 2020, the FDA announced that it had established a U.S. Agent Voluntary Identification System (VIS) in conjunction with their food facility registration database, the Food Facility Registration Module (FFRM), which will facilitate the expeditious verification of U.S. agents for foreign facilities

 By way of background, any U.S. or foreign food facility that is engaged in the manufacturing, processing, packing, or holding of food for consumption in the United States is required to register with the FDA under the Federal Food, Drug and Cosmetic Act. Furthermore, registered  foreign food facilities are required to appoint a U.S. agent to act as a liaison with the FDA and the FDA will not confirm registration or provide the foreign facility with a registration number until the U.S. agent has confirmed that it has agreed to serve as the U.S. agent for that facility.

Under the VIS system, when the U.S. agent adds the facility name and address to their profile and the foreign facility lists the U.S. agent identification number in their registration submission, a registration number will be automatically assigned and the FDA will not take additional steps to verify the U.S. agent. While the speed of verification of the new system incentivizes foreign facilities to use U.S. agents with VIS accounts, it also incentivizes U.S. agents to use the VIS program because it allows them to view any foreign facilities that have named them as their U.S. agent, thus allowing for quick identification of unauthorized or fraudulent registrations.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 294
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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