FDA & FCE

FDA

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:

– Food facilities register with FDA

– FDA be given advance notice on shipments of imported food

FCE

All low acid canned food (LACF) and acidified canned food manufacturers must submit a Food Canning Establishment (FCE) Registration with FDA before exporting to or distributing canned foods in the United States. The FDA FCE Registration is in addition to FDA’s Bioterrorism Act Food Facility Registration requirement. When the FCE Registration is submitted to FDA, the manufacturer must also submit to FDA its Scheduled Process filings for all of its commercially sterile, acidified and low-acid canned foods to obtain a Scheduled Process Identification (SID) Number from FDA for each specific canned food and aseptic or acidified food process.

These regulations became effective on December 12, 2003.

Noble Harvest, LLC will assist you trough procurement of FDA and FCE Homeland Security registration number and mandatory annual US Agent representation.