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FDA Registration & US FDA Agent Representation

We can assist you in registering your food facility with the United States Food & Drug Administration

Owners, operators, or agents in charge of facilities located within or outside the USA that manufacture, process, pack, or hold food for consumption in the United States are required to register the facility with the United States FDA. Facilities that manufacture, process, pack, or hold food are also required to register unless food from that facility undergoes further processing (including packaging) by another non-US facility before the food is exported to the USA.

Examples of FDA-regulated Foods

  • Food and food additives for man or animals
  • Dietary supplements and dietary ingredients
  • Infant formula
  • Beverages
  • 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

What Information Is Required?

  • Name, physical address, telephone number of the facility
  • Same information for the parent company, if the facility is a subsidiary
  • All trade names the facility uses
  • Food product categories
  • A statement certifying that the information submitted is true and accurate and submitter is authorized to register the facility
  • Name and contact information of the person submitting the certification statement
  • Name of foreign facility's U.S. FDA agent and the agent's contact information
  • Emergency contact information

We can act as your U.S. FDA Agent for your Facility

The U.S. FDA agent acts as a communications link between FDA and the foreign facility. FDA treats representations by the U.S. FDA agent as those of the foreign facility, and will consider information or documents provided to the U.S. FDA agent equivalent to providing the information or documents to the foreign facility. A U.S. FDA agent cannot be in the form of a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's U.S. FDA agent is not physically present.

Farms; retail food establishments; restaurants; non-profit establishments that prepare food for, or serve food directly to, consumers; fishing vessels not engaged in processing and facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture are exempt from registration.

U.S. Congress Approves Food Safety Legislation, expands FDA’s Authority to Regulate Food Imports into the USA

  1. Establishes foreign supplier verification program
  2. Requires import certifications for food products in certain circumstances
  3. Establishes a voluntary qualified importer program
  4. Inspection fees for registered facilities
  5. Increases inspections over the next five years
  6. Authorizes FDA to recall unsafe foods and suspend food facility registrations associated with unsafe food

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