Establishment Registration
U.S. Agent
FCE / SID
Labeling

Establishment Registration for Food companies

• The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.
  
• Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.

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U.S. Agent for foreign food companies

• This is a requirement for all foreign facilities (located in outside of U.S.). U.S. Agent means an entity located in the U.S. that is designated by a foreign facility for purposes of the registration regulation. The U.S. Agent acts as a communications link between FDA and the foreign facility. It is important to note that the US Agent here is not an agent for commercial or distribution purpose.
  
• It is important to register facilities and designate a US Agent before importing into the US.

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FCE (Food Canning Establishment) and SID (Submission Identifier)

• The FDA requires registration, manufacturing, and process filing for low-acid canned foods (LACF: ph of 4.6 or above and water activity of 0.85 or above) and acidified foods (AF: ph of 4.6 or below and water activity of 0.85 or above) in hermetically sealed containers.
  
• After completing all registrations, process filing and relevant studies, the FCE number and SID can be issued. The application for the FCE number requires information on adequate processing, controls, and appropriate processing methods, such as cooking the food at the proper temperature for sufficient times, adequately acidifying the food, or controlling water activity.
  
• The facility registered for the FCE needs to comply CGMP (Current Good Manufacturing Practice) regulations.

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Labeling: Supplement Facts and product descriptions

• Supplement Fact is mandatory for all dietary supplements. The labeling issue is perhaps the most important compliance issue for dietary supplements.
  
• The FDA pays special attention to the product description to confirm if the description is not misleading or false. The FDA does not allow the description such as "cure, treat, or prevent of a disease" as those health claims are only for drugs.

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