The Clock Ticks Away on AAFCO’s Ingredient Definition Process

August 22, 2012

By Ricardo Carvajal & Diane B. McColl

Back in April, FDA’s Center for Veterinary Medicine ("CVM") notified industry of its decision to extend the agency’s Memorandum of Understanding ("MOU") with the Association of American Feed Control Officials ("AAFCO") for one year (the MOU was scheduled to expire on September 1, 2012).  As of September 1, 2013, CVM intends to “transition from being the active reviewers of individual Ingredient Definition submissions to serving as a liaison and advisor to the Ingredient Definition Committee.”  However, CVM intends to “stop accepting requests to review new Ingredient Definition submissions” much sooner, specifically as of February 2013.  This means that the window of opportunity to petition for a new or revised Ingredient Definition through AAFCO is now down to six months.

The February deadline is intended to give CVM time to finish pending Ingredient Definitions, and to redirect the “increasing resources needed to address food additive petitions and [GRAS] notices.”  However, a cursory review of CVM’s inventory of GRAS notices reveals that none are pending.  Since CVM started receiving GRAS notices in 2010, a total of 13 notices have been filed.  Of those 13 notices, 3 received no objection letters, 4 received objection letters, and the remaining 6 were withdrawn.  Query whether the low rate of submissions is in part a function of these discouraging statistics.