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The U.S. Food and Drug Administration regulates most food and beverage products
sold in the United States. Companies selling these products must meet very specific requirements set forth by the U.S. Federal Food, Drug, and Cosmetic Act which was originally passed by Congress in 1938 and has subsequently been amended by Acts such as the Bioterrorism Act in 2002 and more recently by the Food Safety Modernization Act in 2011.


One of these requirements is that food facilities must register with the U.S. FDA. A "facility" is any establishment, warehouse, or factory that manufactures, processes, packs, or holds food that may be consumed by humans or animals in the United States.


The registration of food facilities helps FDA determine the location of the source of a potential or actual bioterrorism incident or an outbreak of food-borne illness, and permits the agency to quickly notify facilities that may be affected. Examples of foods that may be produced in a facility required to have an FDA food facility registration include, but are not limited to:
- Dietary supplements and ingredients
- Beverages (including alcoholic beverages and bottled water)
- Infant formula
- Fruits and vegetables
- Seafood
- Dairy products and eggs
- Bakery goods, snack food, and candy
- Live food animals
- Animal feeds and pet food


Some facilities may be exempt from registration and include:
- Private residences of individuals
- Farms
- Restaurants
- Retail food establishments
- Nonprofits
- and facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture


Each food facility is required to have its own registration number. If products from one facility are moved to a different facility, the second facility may also be required to register. Large corporations may own or operate multiple facilities. Each facility may be required to register and obtain different food facility registration numbers. Failure to register a facility, update required elements, or cancel a registration in accordance with this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act.


As part of a facility's registration, food facilities located outside the United States must provide contact details for a U.S. agent for FDA communications. This is different from a commercial agent such as your importer or broker. A U.S. Agent for FDA purposes
facilitates communication between the FDA and the foreign food facility. The U.S. Agent must be available for FDA to contact 24 hours a day, 7 days a week. FDA will contact the U.S. Agent to schedule inspections of the foreign facility or to even ask questions about a specific shipment of food to the U.S. In responding to FDA, the U.S. Agent is speaking on behalf of the registered foreign facility. So it's very important to use a reliable U.S. Agent that understands FDA regulations.


Think twice before listing an importer, distributor, or relative as your U.S. Agent for FDA communications. A relative often does not have a full understanding of U.S. FDA regulations and an importer/distributor may have a conflict of interest with your regulatory needs. Further, a good U.S. Agent should be knowledgeable about all FDA regulations and always available in the event of an emergency.


By registering, you are giving FDA the right to inspect your facility. Not only will the inspector seek to verify that your registration information is accurate but he will also verify other FDA requirements such as Good Manufacturing Practices, Labeling Compliance, and HACCP.


Additionally, the production of certain products such as canned and smoked foods may be subject to additional regulations and record-keeping requirements. The Food Safety Modernization Act also mandates that FDA shall charge the U.S. Agent listed in the food facility registration hourly fees for any re-inspections of a foreign food facility.
These fees could amount to thousands of dollars.


While registering a facility may sound simple, a number of mistakes are frequently made. Mistakes in the registration can have grave consequences for your business,

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