Independent Panel Recommends Significant Changes to Food Regulation by FDA
(Thursday, December 8, 2022)
An external panel of experts tasked with reviewing FDA’s current practices for regulation of food supply chain recommended a proactive approach to supply chain regulation and restructuring FDA’s organization to create clearer leadership at FDA for food regulation. These organizational changes, if implemented, will streamline FDA’s oversight of food supply chain without necessarily creating new rules for the food industry. The FDA is directly responsible for regulating about 78% of the food supply in the US in various ways such as setting up standards for food safety, nutrition, labeling, and regulation of suppliers. FDA currently relies primarily on food labeling, consumer education, and identifying and responding to acute outbreaks of foodborne illnesses and death for regulating food. The Center for Food Safety and Applied Nutrition (CFSAN) is the primary center responsible for FDA’s food regulatory programs assisted by the Office of Food Policy that creates guidelines and policies, and the Office of Regulatory Affairs (ORA) that conducts surveillance and for cause inspections and investigations of food safety events. The panel concluded that the current regulatory practices at FDA related to food supply regulations are reactive rather than proactive. It recommended several policy and cultural changes at FDA. First, it would like to see a reorganization of FDA leadership to create a clear leader with well-defined roles and responsibilities, a change from the current structure where the various offices report directly to the FDA Commissioner with minimal cross-collaborations. The panel suggested five options for organizational changes within FDA, some that would take minimal time to implement such as assigning CFSAN as the leader, separating CFSAN from ORA so CFSAN can do its own inspections and surveillance. Other recommendations such as creating a new Deputy Commissioner for Food or separate Food Administration independent of FDA would require major restructuring and hence would likely take much longer to implement and may require Congressional approval. The panel recommended various cultural changes to the perspectives for food regulation within FDA personnel which emphasize the current regulatory responsibilities and associated tasks. Many of these suggested cultural changes do not seem new and may require FDA to primarily jig its current policies within the new administrative structure proposed by the panel. The panel also recommended that FDA increase its cooperation and collaboration with states and other local authorities, have its personnel attend more outside conferences on food supply chain and safety related issues, and conduct more internal and external research of food programs. Lastly, the panel suggested that FDA explore user fees to fund the suggested changes to the food program. FDA has committed to review and implement the recommendations by the panel. For the food industry, these changes should lead to greater oversight and likely user fees but few changes to the applicable regulations.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC