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New FDA Requirements



FDA Requires Food Facilities to Register by December 12


For your information, the following U.S. Food and Drug Administration (FDA) interim regulations relating to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) may soon require action on your part:


1.         Registration of Food Facilities.  Requires all domestic and foreign owned businesses with facilities in the United States that manufacture/process, pack or hold food for humans or animals must register each facility with the FDA by December 12, 2003.

This requirement pertains to facilities that manufacturer/process, pack, or hold food such as: 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 and frozen foods; bakery goods, snack food and candy; live food animals; and, animal feeds and pet foods.

Facilities exempt from this requirement include private residences, non-bottled water drinking water collection and distribution, transport vehicles used only as carriers of food, farms, restaurants, retail food establishments, nonprofit food establishments, fishing vessels, and facilities regulated exclusively and throughout the entire facility by the USDA.


2.         Prior Notice of Imported Food Shipments.  Requires that prior notice must be submitted to the FDA for each article of food imported or offered for import into the U.S. before the food (same items listed above) arrives at the port of entry beginning December 12, 2003.


For further information on these regulations, we urge you to visit the FDA website at and click on "Bioterrorism Act".  For assistance with on-line registration: in the U.S. CALL 1-800-216-7331 OR (301) 575-0156; or send fax to (301) 210-0247.  You may also request assistance via e-mail at [email protected].  Online Registration Help Desk will be staffed on business days from 7 AM until 11 PM Eastern Time.  Or you may write to the following address:  US FDA  HFS-681, 5600 Fishers Lane; Rockville, MD  20857


To view memo in PDF format, click here