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FDA Requirements for Reportable Foods

The U.S. Food and Drug Administration (FDA) requires that all food facilities registered with FDA report when there is a reasonable probability that the use of or exposure to an article of food will cause serious adverse health consequences or death to humans or animals via the Reportable Food Registry (RFR).  Federal, state, and local government officials are also permitted to use the RFR to voluntarily report information about reportable foods.

The RFR was established so that FDA would have a reliable method to track patterns of adulteration in food and to target inspections.  Creation of the RFR was mandated by section 417 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a new section that came about after the president signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA).  The RFR became available as an electronic portal on FDA.gov on September 8, 2009.  In May 2010, however, a new version of the RFR was released as part of the FDA-NIH Safety Reporting Portal.

Reports are to be submitted to the RFR no more than 24 hours after the food is determined to be reportable.  The responsible party must investigate the cause of the adulteration and include this information in the report.  An RFR report is not required to be submitted if all of the following are true:

  • The adulteration originated with the responsible party
  • The responsible party detected the adulteration prior to any transfer of the food to another person
  • The responsible party corrected such adulteration or destroyed such article of food

FDA suggests creating an account within the Safety Reporting Portal so that you don’t have to re-enter basic information (name, address, etc.) each time you submit a report, and so that you can save reports to finish later and view previously submitted reports.  Users that do not create an account cannot view previous submissions or save reports to be completed later.  The RFR is currently only available in English.  FDA also encourages that information submitted to the RFR be in English, or at least be accompanied by an English translation.

A food may be classified as reportable for a variety of reasons.  It could be due to a labeling issue, such as a product that contains nuts not indicating so on the label.  A food may be contaminated with salmonella or listeria monocytogenes, or a pet or baby food could pose a choking hazard.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations.  We assist food facilities with FDA registration, prior notice submissions, labeling compliance, and more.  Contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists any time at https://regstaging.wpengine.com/livehelp.