FDA’s Reportable Food Registry Moves One Step Closer to Reality

By Ricardo Carvajal –      

FDA recently published a notice of a proposed collection of information that solicits comments on the use of its new electronic system, called MedWatch^Plus Portal, for the collection, submission, and processing of adverse event reports and other safety information for all FDA-regulated products.  FDA intends to use the new system to meet the agency’s obligations under § 417(b) of the FDC Act – added by § 1005 of the FDA Amendments Act of 2007 ("FDAAA") – which requires that FDA establish a Reportable Food Registry and electronic portal by September 27, 2008.  As we discussed more fully in our FDAAA summary, § 417(d) requires a responsible party to submit an instance of a reportable food to the electronic portal within 24 hours for possible inclusion in the registry.  That reporting requirement went into effect on September 27.  However, FDA previously acknowledged that it would not meet the September deadline for establishment of the electronic portal, and indicated that it was developing a system that was expected to be operational in Spring 2009.  The agency appears to be on track to meet its target date.  In the interim, FDA has instructed industry to continue reporting instances of food adulteration to the relevant FDA District office.