— OPINION —

By Jim O’Hara

For the first time in many years, the Food Program at the Food and Drug Administration is under serious scrutiny by Congress and the press, most visibly regarding the Abbott infant formula safety and shortage controversy.  

In April, however, a broad coalition of food industry trade associations, consumer groups, and FDA’s state regulatory partners raised much more extensive concerns about the program’s shortcomings stemming from its fragmented organizational structure and divided leadership.  The coalition called for organizational unification of the program under a deputy commissioner with the expertise and authority to provide the integrative leadership and accountability the program needs.  

Then, in July, FDA Commissioner Robert Califf announced that an external group of experts will conduct “a comprehensive evaluation” of FDA’s Human Foods Program to address “fundamental questions about the structure, function, funding, and leadership of the program.”   

Most recently, a group of former FDA food safety program officials has put forward a road map for a new governance structure for this expert panel to consider. 

Yet, some current and former leaders of FDA seem to be clinging to the organizational status quo, as though they believe the earth is flat and that the Federal Food, Drug, and Cosmetic Act of 1938 and FDA’s traditional management paradigm for food safety remain sufficient today.

But, in fact, the globe has been circumnavigated. Earth has been viewed from space.  Most importantly, the Food Safety Modernization Act (FSMA) of 2011 has been passed and calls for a new paradigm of food safety.

The food safety concerns of 80 years ago focused on the adulteration of food products and consumer fraud by unscrupulous businesses. Food production was mostly domestic. From those facts, a culture evolved at FDA: catch the bad guys, present solid scientific evidence of their wrongdoing in court, and go after the next bad guy.

Today, we routinely eat foods grown, harvested, and processed from around the world.  Our understanding of the risks of microbiological contamination possible in food production and its impact on our health compared to 80 years ago is the difference between the Apollo program and the Model T.

A new culture of prevention needs to spring from those facts — one in which all elements of FDA’s Food Program are pulling together in the same strategic direction to keep food safe. FSMA demands no less of FDA because FSMA demands so much more. 

FSMA expanded FDA’s food safety mission far beyond its historic focus on U.S.-based food manufacturing facilities to encompass for the first time more than 100,000 fresh produce farms in the U.S. and overseas and many tens of thousands of foreign manufacturers and their U.S.-based importers and feed importers. 

FSMA directed FDA to create new programs for defending the food and feed supply from intentional adulteration, improving the traceability of food, and establishing a new “national integrated food safety system” in partnership with state food regulators. 

Congress mandated in FSMA that human food, pet food, and feed for food animals all be regulated under a common holistic framework of regulatory standards for prevention, making obsolete the thick wall that currently separates the parts of FDA regulating human and animal food. 

Finally, to make FSMA a success, FDA’s Office of Regulatory Affairs (ORA), which conducts vital inspection and enforcement activity, requires a cultural transformation of its own. It must move from inspection and reaction to safety problems as ends in themselves to an ethos of public health prevention, pursued now on a global basis.  

ORA must work seamlessly, flexibly, and in full transparency with the Food Program’s science and policy leaders. And it must be accountable to them for implementing new strategies that incentivize prevention and the implementation of best practices across the food system.

To think that FDA’s fragmented and siloed management structure can accomplish all this is to believe that 16^th century galleons are capable of the discoveries of the James Webb Space Telescope.  

As the former FDA food safety officials have proposed in their road map for the future, a single, authoritative focal point for leadership of the overall Food Program in the person of a deputy commissioner is needed, along with a unified executive team that together can elevate the priority and power of the Food Program within FDA and enable the program to speak with a unified voice and consistent message. This will strengthen the Food Program in its competition with the medical product programs for FDA resources and externally in engaging stakeholders and state regulatory partners.    

By not recognizing and acting on these changes and needs, FDA’s leadership and its allies are in danger of sailing FDA’s food safety mission right off the edge of the world.

about the author: Jim O’Hara was FDA’s Associate Commissioner for Public Affairs from 1993 to 1997 and managed the public affairs rollouts of the Nutrition Facts label and the Hazard Analysis at Critical Control Points (HACCP) initiative for seafood. From 1997 to 1999, he was the Deputy Assistant Secretary for Health and served on the Clinton Administration’s inter-departmental committee to coordinate food safety efforts.  He also served as Executive Director of the Produce Safety Project, an initiative of The Pew Charitable Trusts to build support for FDA to establish produce safety regulations.