FDA Reportable Food Registry

The Reportable Food Registry (RFR) is an electronic portal for food producers to notify the U.S. Food and Drug Administration (FDA) when there is reasonable probability that a food product will cause serious adverse health consequences.  It was established by the FDA as a means of improving communication between the food industry and the agency.

Reportable Food Registry requirements contained in section 417 of the Federal Food, Drug and Cosmetic ACT (FDCA) went into effect on September 8, 2009.

Section 417 of the Federal Food, Drug, and Cosmetic Act (FDCA) requires a “responsible party” to submit to FDA a report within 24 hours after the responsible party determines that an article of food is a “reportable food.”

  • A “reportable food” is defined in Section 417 as “an article of food (other than infantformula) for which there is a reasonable probability that the use of, or exposure to, sucharticle of food will cause serious adverse health consequences or death to humans or animals.”
  • A “responsible party” is defined “with respect to an article of food” to mean a person who submits a food facility registration “for a food facility…at which such article of foodis manufactured, processed, packed, or held.”

Click here for the FDA Web site containing access to the Reportable Food Registry.

Click here for FDA's Guidance for Industry issued June, 2009, and revised September, 2009: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007

Click here for FDA's Guidance for Industry issued March, 2010:  Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007

Reportable Food Registry Webinar

On April 6, 2010, AFFI hosted a Webinar on the Reportable Food Registry, which included a presentation from Gary Jay Kushner of Hogan and Hartson, LLC.  

Click here for access to the webinar presentation - (Members Only)

FDA's Guidance for Industry issued June, 2009, and revised September, 2009Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007
FDA's Guidance for Industry issued March, 2010Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007
AFFI's April 6, 2010, Webinar on the Reportable Food RegistryPresentation by Gary Jay Kushner of Hogan and Hartson