FDA and NIH Launch Food Safety Reporting Portal

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June 1, 2010

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched the Safety Reporting Portal web site, which provides increased access to all interested parties, including concerned citizens, to submit reports concerning regulated products.

“As access to this internet tool increases, the number of safety reports to FDA will certainly increase as well,” said Benjamin L. England, Food and Drug Law professional and founder of FDAImports.com LLC, a consulting firm that specializes working inside the FDA. “Because some safety reporting is mandatory for certain products by some private manufacturers and processors, ‘required organizations,’ use of the [portal] will become the upgraded replacement for all safety reporting to FDA.”

For instance, England said the portal now replaces the FDA’s previous Reportable Food Register. Another upgrade to the electronic and online reporting system permits consumers to submit reports concerning adverse events and products.

“Currently, in order to report an adverse event to FDA, even federal investigators, as well as required organizations, must submit duplicate reports to several federal agencies,” England noted. “Each of these reports requires use of different forms, vocabularies, reporting timeframes and criteria. The [portal] standardizes all submitting requirements across commodities, industries and market participants. “

Previously, multiple agencies were receiving the same safety report in varying formats. This had the potential to cause confusion among government authorities concerning which department should investigate and potentially take enforcement action, he added.

“[The portal] shows that FDA and NIH are serious about taking action toward uniting and coordinating the diverse federal requirements that are currently in place for the reporting and reviewing of adverse events,” England said.

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