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FDA Enhances Reportable Food Portal, Issues Revised Guidance

May 28, 2010

The Food and Drug Administration on Monday announced a number of changes and enhancements to the Reportable Food Registry portal and issued revised industry guidance to clarify a number of issues. The portal is now part of the agency's multi-faceted Safety Reporting Portal

Users of the Reportable Food portal will now be able to create and maintain an account that will be pre-populated and ready to use when needed. Another new feature allows users to start a report and save it prior to submission if they need to collect further information.

"Users also may 'play around with the system,' creating sample reports, as long as they do not press submit," said Clay Detlefsen, IDFA vice president of regulatory affairs. "We believe these changes will be of considerable benefit to our members."

The Reportable Food portal, which became active last September, is intended to improve FDA's ability to ensure the safety of the domestic food supply. It requires a company to file a report when there is reason to believe that an adulterated food, other than infant formula, will cause serious adverse health consequences or death to humans or animals.

FDA Amends and Adds Details in Guidance

FDA also this week issued the "Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition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)." This edition clearly identifies the questions and answers that have been amended or added as of May 2010.

In addition, FDA has asked for written comments on the transfer issue that has troubled many food manufacturers. Currently, companies are not required to submit a report if the adulteration originated at the company, if it was discovered before being transferred and if it was corrected or destroyed. However, if companies find that they have transferred an adulterated food product to other persons, they will be obligated to report.

In addition, once a product leaves the company's possession and has tested positive for the presence of a pathogen, it must be reported, even if subsequent testing turns out to be negative. The conundrum, according to Detlefsen, is that a change in physical possession in many cases does not equate to a change in control. Many food processors use third-party warehouses but retain full control over their products.

IDFA believes FDA has a good understanding of the issues that concern dairy processors and expects the agency will likely make improvements to the requirements once the rulemaking process has concluded.

Members with questions may contact Detlefsen at or (202) 220-3554.


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