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FDA Structure in Relation to Food Oversight

08/03/2023

Three former senior officials at the Food and Drug Administration (FDA) including Dr. Stephen Ostroff, Dr. Michael Taylor and Dr. David Acheson submitted written and oral testimony to Congress relating to restructuring of the Agency. Collectively the three officials tasked with food safety served from 2007 through 2018 bracketing enactment of the Food Safety Modernization Act of 2011.

 

Numerous observers have supported the Reagan-Udall Foundation recommendation to appoint a Deputy Commissioner of the FDA responsible for all aspects of nutrition and food safety including R&D, inspections, compliance and enforcement.

 

The current Commissioner of the FDA, Dr. Robert Califf, has opted not to follow recommendations to consolidate food within his Agency based on the fact that this would require profound changes to culture and interaction along existing functional (or dysfunctional) components. Industry and consumers need a cohesive agency that will address challenges and implement the Food Safety Modernization Act.

 

The three previous FDA Deputy Commissioners regard the proposed restructuring as perpetuating the “fractured structure and divided lines of management accountability we know will not work”. The alternative of moving the food-related activities under a separate Commissioner within the U.S. Department of Health and Human Services would require Congressional approval and would encounter a delay before implementation. 

In the event of a serious food safety issue reflecting the magnitude of the infant formula crisis or following a widespread food toxicity or foodborne infection, Congress may move with haste to rectify obvious problems that stem from an inappropriate structure and neglect of oversight.  An example of a rapid reorganization is the creation of the Department of Homeland Security that combined agencies and functions in the aftermath of a national tragedy.  Congress should act to separate all food-related activities from the current FDA to be placed under a qualified and motivated Commissioner establishing a parallel to what would remain as the Federal Drug Agency. As the Washington observers remark, the ‘F’ in FDA is silent!