What does FDA’s New Reportable Food Register mean to you?

The  Food and Drug Administration Amendments Act of 2007 (FDAAA) is the current law governing this register.  It was signed into law  September  2007 amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) with a new called the Reportable Food Registry (RFR-Section 417).   This section’s purpose is  to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health”.

Who does this apply to? All facilities that manufacture, process, pack, or hold FDA-regulated food or animal feed for consumption in the U.S., and Federal, state, and local public health officials.

What needs to be reported? A reportable food is any food that has a probability of causing serious adverse health consequences or death to humans or animals. Examples include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.  Facilities must notify FDA as soon as possible, and no later than within 24 hours.

What information will need to included in the report? ( from http://rfr.fda.gov/)

  • Introduction (5 minutes) – The type of report you are submitting.
  • Responsible Party / Reporter Information (4 minutes) – Your identifying information. To submit a report, responsible parties must have a Food Facility Registration Number for the Responsible Party site and the Location of Reportable Food. Please visit Registration of Food Facilities for more information on how to register for this number.
  • Location of Reportable Food (4 minutes) – The contact information for the site about which you, the responsible party are reporting; this may be the same or different from your site. This site may have discovered the problem on its own or may have been notified about the problem by another source. If you are a Federal, State, or local public health official, this section asks you to report about the location that is the current manufacturer, processor, packer, or holder of the food to the best of your knowledge.
  • Problem Origination Site (4 minutes) – You will only see this section if you indicate that you know the site at which the problem originated; that is, where the problem started. This section asks you to provide the name and any other information you might know about that site/location.
  • Product Problem (5 minutes to 15 minutes, depending on how much information you are able to provide at this time) – This section asks for a summary of the product problem, including how and when you learned about the problem, information about the suspect products (received or produced), and a description of the problem. If you have more details about any of the suspect products, you will be asked to provide them.
  • Submit report and Confirmation (5 minutes) – This section provides an opportunity to review your report before submission, instructions for attaching supplemental information to accompany your report, and provides you with an FDA-issued unique identifier number (also known as an Individual Case Safety Report number, or ICSR number) with which to identify your report. Upon submitting the report, you will have the option to send FDA additional related materials via email.

Here is the link to questions: Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendment Act of 2007

Instruction for filling out the Reportable Food Register

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