FDA Releases Draft Guidance for Mandatory Food Recalls

On May 7, 2015, the Food and Drug Administration (FDA) published a draft of planned guidance for the implementation of the mandatory recall authority established with the Food Safety Modernization Act of January 2011.

The guidance serves to highlight the FDA’s current thinking on the recall authority and how industries can comply with the existing regulations, creating no new duties or regulations on the part of the FDA or industry in general.

The draft provides the definition of “food”, “responsible parties”, and “person” within the Food, Drug, and Cosmetics Act. The draft also explains how the FDA determines when a food is considered adulterated or misbranded and what evidence might be considered.

The criteria for a recall are met when there is a reasonable probability of adulteration or misbranding as well as a reasonable probability of serious adverse health consequences or death to humans or animals. The draft then outlines the process for the recall, beginning with the opportunity for a voluntary recall and in the event of non-compliance the FDA may order a recall. To date, this power has only been exercised twice.

Public comment on the draft guidance is open until July 6, 2015, and may be submitted here.

Written by Tyler R. Etter - Research Assistant
June 3, 2015