Food Facilities Must Register with FDA

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires all non-U.S. facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.

Examples of Food

Many types of food are included, like Tea & Coffee, Food and food additives for man or animals, Dietary supplements and dietary ingredients, Infant formula, Beverages (including alcoholic beverages and bottled water), Fruits and vegetables, Fish and seafood, Dairy products and shell eggs, Raw agricultural commodities for use as food or components of food, Canned foods, Live food animals, Bakery goods, snack food, and candy. To be save, consider any food as covered by these rules.

Affected Facilities

The Bioterrorism Act defines foreign facilities as any establishment, structure, or structures under one management at one general physical location, or, in the case of a mobile facility, traveling to multiple locations that manufactures/processes, packs, or holds food for consumption in the United States. Often exporters need to register multiple facilities where food is stored, packed and prepared for shipment.

Register & U.S. Agent

Each foreign food facility must be registered with the FDA and a registration number will be provided. A foreign facility must designate a U.S. agent. The agent may also register the foreign facility. The U.S. agent needs to be a person residing or maintaining a place of business in the United States, available to assist FDA in contacting the foreign facilities, act as a communications link between FDA and the facility and be able to register on behalf of the foreign facility. Only one U.S. agent per foreign facility is permitted.

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We are here to assist you with the FDA registration process and we act as your U.S. Agent for the FDA.