The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect public health by tracking patterns and targeting inspections. The Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085), section 1005 directs the FDA to establish a Reportable Food Registry for Industry.
The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula.”
It is the company’s responsibility to determine if the food has a reasonable probability of causing a severe adverse health consequence or death to humans or animals (SAHCODHA). Once a SAHCODHA has been determined to exist, the company must notify the FDA using the RFR system within 24 hours of the determination. Note that the RFR uses the company’s registration number generated when the company registered in compliance with the Bioterrorism Act.
FDA’s Reportable Food Registry Guidance for Industry may be accessed at: www.fda.gov/ReportableFoodRegistry
Download the following document for more information: RFR at a Glance (pdf)