FDA Expands Reportable Food Registry Reporting Requirements

FDA announced on June 4, 2012 that it has significantly expanded the information it will seek from a company reporting to the Reportable Food Registry. The new data elements will initially be voluntary but will become mandatory later in the year. FDA's announcement marks the first major revision to the Reportable Food Registry ("RFR") since it went into effect in September 2009.

Previously, the RFR required submission of only a limited amount of information, such as the companies and products involved, a description of the problem leading to the report, how the company learned of the problem, a description of the investigation, affected product information, and whether any adverse events had been reported. Companies will now also need to provide FDA with significantly more information, including why the product is being reported; a root cause analysis; justification as to the company's selection of particular lots or batches being reported; corrective actions; whether the product underwent an antimicrobial treatment and, if so, a description of that treatment; whether a bacterial isolate is available for FDA collection; and whether the company has already notified its suppliers and customers. For animal feed and pet food, companies will also need to report the intended species for the product and the life stage of the animal to which product was fed (e.g. calves versus heifers versus lactating cows).

While RFR reports have always been considered "safety reports" and therefore not admissible in court proceedings to show a product was contaminated or caused illnesses, these new data elements raise serious concerns for future litigation. In particular, since RFR reports are subject to Freedom of Information Act requests, potential litigants may use the expanded RFR reports as a roadmap for compiling their Complaints.

As a reminder, the RFR requires food, feed, and dietary supplement facilities registered with FDA to make a report on the online portal any time a facility learns there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals—essentially a Class I recall standard. Reports must be made within 24 hours after learning of the potential problem, after a reasonable investigation. There is a limited exemption if the problem originated with a facility, the company detected the problem before the food left the facility, and the facility has either corrected the problem or destroyed the food before it left the facility. 

For more information on the Reportable Food Registry, please see our previous article and presentation.  Please feel free to contact us with any questions.