It’s Official – FDA States Intention to Exercise Enforcement Discretion for Key FSMA Provisions

By Ricardo Carvajal –

In several letters issued to trade associations on June 18th (for an example, see here), FDA stated that it “will expect to enforce compliance” with the preventive controls provision in section 103 of the Food Safety Modernization Act ("FSMA") and the foreign supplier verification provision in FSMA section 301 “in timeframes that will be described in the final rules.”  Given that the proposed rules for those provisions have yet to publish, it is clear that industry will have substantial additional time to come into compliance with the requirements in those provisions.  However, that time will not be unlimited.  If the delay in publication of proposed and final rules proves too protracted, consumer advocates can be expected to put FDA’s feet to the fire.