FDA's Self-Assessment of the Reportable Food Registry

September 16, 2010

The Food and Drug Administration (Rockville, MD) held a teleconference last week highlighting the agency...s first seven months of experience using its new Reportable Food Registry. The Reportable Food Registry is an online portal that enables food manufacturers and other bodies to submit online reports of adverse events.

The Food and Drug Administration (Rockville, MD) held a teleconference last week highlighting the agency...s first seven months of experience using its new Reportable Food Registry. The Reportable Food Registry is an online portal that enables food manufacturers and other bodies to submit online reports of adverse events.

'We know that even as we build a stronger prevention system to minimize contamination incidents, we will get incidents and we will get problems occurring,' said Ira Allen of FDA...s office of public affairs. 'So, part of the prevention system is to be able to obtain rapidly and to share between government and industry information on these incidents so we can act quickly to keep the products from reaching consumers.'

In assessing the Registry...s role in motivating more efficient adverse event reporting, Allen said, 'It...s a very important complement because it doesn...t rely on us being at a facility or sampling the product ourselves to detect problems" [and] it is a complement to a number of ways in which we learn about problems.'

Over these first several months, FDA states that close to 125 'primary' reports were received out of over 1800 reports in total. 'Of the 125 reports, looking at the data, there was one [report] that did have an adverse event, and it actually resulted in a recall,' said Kathy Gombas, acting deputy directory of FDA...s Office of Food Defense Communication and Emergency Response. 'The company had received one report of four family members who had an adverse reaction to the product. It was an allergic reaction and that was the only one that actually caused a serious adverse condition. All the others had the potential, but did not result in [a recall].'

For more information or to access the Reportable Food Registry, click here.