FDA Registration

FDA Food Facility Registration

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, and
FDA be given advance notice on shipments of imported food.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that

Facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.

Why register with MAGNECO?

The new FDA Food Safety Modernization Act (FSMA) requires Biennial Registration Renewal for domestic and foreign Food Facilities. Previously registered facilities should renew the registration between October 1 and December 31 of each even-numbered year.
Every foreign food facility must have a U.S. FDA Agent who acts as the domestic communications representative for that facility. Foreign facilities must provide the US FDA agent information at the time of FDA registration, and must update the FDA registration information if the facility changes the US FDA agent.