U.S. FDA Compliance
explained
The U.S. FDA ensures the safety and proper labeling of food sold in the United States, both domestically produced and imported. This falls under the jurisdiction of the FD&C Act and the Fair Packaging and Labeling Act.
U.S. FDA Requires only food facility to register that manufacture, process, pack, or hold food for human or animal consumption in the U.S.
The food facility registration process with the US FDA underwent changes with the implementation of the FDA Food Safety Modernization Act (FSMA) in FY 2012. Under FSMA, domestic and foreign food facilities must renew their registration biennially, between October 1 and December 31 of each even-numbered year since 2012. Facilities must update registration information within 60 days of any changes or cancel registration within the same timeframe if operations cease. Previously registered facilities without registration information can contact the US FDA directly for details. Foreign food facilities are required to designate a US FDA Agent for communication and must update agent information during registration changes.
This registration process, along with prior notice requirements, aids the US FDA in tracking the origin and distribution of food products, facilitating rapid responses to potential threats to the US food supply. Statistics from March 2, 2023, indicate a total of 208,034 food facility registrations, comprising 87,729 domestic registrations and 120,305 foreign registrations.
ABOUT FSMA
New FDA Food Safety Modernization Act (FSMA)
FDA Registry assists with U.S. FDA food facility registration, compliance with FDA bioterrorism act requirements, and provides U.S. FDA Agent services for foreign food facilities.
NOTE
U.S. FDA does not issue certificates or recognize third-party certificates. Each facility is assigned a registration number, not indicative of FDA approval.