On October 1st FDA announced food facility registration system is not yet ready for industry, despite requiring all foreign and domestic facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to renew their food facility registration by that time.
Under the Bioterrorism Act FDA required all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to file a food facility registration by December 12, 2003. Registration can be completed at no cost by either completing an on-line form, paper form or submitting a CD-ROM with applicable information. This system is designed to facilitate rapid notification of the FDA and assist in handling situations involving bioterrorism or outbreaks of food-bourne illnesses1.
Under the Food Safety Modernization Act (FSMA), all domestic and foreign food facilities are required to renew their food facility registration with the FDA between October 1st and December 31st, beginning in 2012 and continuing thereafter each even-numbered year. However, on October 1st, the FDA announced the registration system for the renewals was not ready and they were unable to confirm when it would be ready2.
If you were not aware of this new requirement, you need to be. While the FDA may get away without being prepared, you will not. Failure to register your facility or renew its registration is a prohibited act under the Food Drug & Cosmetic Act. Additionally, if you are a foreign facility, the food products (including dietary supplements) you are importing into the U.S. are subject to refusal.
dicentra will be sure to advise you when the FDA food facility registration system is available. If you have any questions, please contact us.
References:
1. http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081610.htm 2. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/registrationoffoodfacilities/default.htm