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U.S. Department of Health and Human Services

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What is the Reportable Food Registry?

An electronic portal to which industry must, and public health officials may, report when there is a reasonable probability that an article of human food or animal food/feed (including pet food) will cause serious adverse health consequences or death to humans or animals. Congress mandated that FDA establish the Reportable Food Registry (RFR or the Registry) in Section 1005 of the FDA Amendments Act of 2007.

 

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What foods are covered by the RFR?

All foods regulated by FDA except infant formula or dietary supplements, which are covered by other mandatory reporting systems. The RFR does not receive reports about drugs or other medical products, reports about products under the exclusive jurisdiction of the U.S. Department of Agriculture, or reports from consumers, for whom FDA has other reporting systems.

How has FDA improved the RFR since the portal opened in September 2009?

On May 24, 2010, FDA and the National Institutes of Health (NIH) launched the Safety Reporting Portal (SRP), a new web site for reporting several types of problems, including the Reportable Food Registry. The SRP replaces the electronic portal FDA launched in September 2009 for the Reportable Food Registry. The SRP features more user-friendly software than previously available on the former Reportable Food portal. Responsible parties and/or public health officials can open accounts which allow them to save partial or completed reports; have new or amended reports pre-populated with much of their information; view any previous submissions they have made via the SRP; and submit attachments as unified parts of their submissions. Concurrently with the launch of the SRP, FDA published Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) containing draft instructions to aid responsible parties and/or public health officials when submitting Reportable Food reports via the SRP.

Is help available for food facilities that have questions about the RFR?

FDA has created an RFR main page at www.fda.gov/ReportableFoodRegistry, which provides detailed information about the RFR and includes a link to the RFR Draft Guidance for Industry (also available in Spanish, French and Chinese). FDA also provides two email RFR help desks:

 

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