Food and Drug Administration Commissioner Robert Califf has proposed creating a new Human Foods Program at the agency and has begun a national search for a newly created deputy commissioner for human foods who would report directly to him.
In a statement, Califf said his “new, transformative vision for the FDA Human Foods Program” follows the recommendations outlined in the Reagan-Udall Foundation report, as well as a separate review of the agency’s infant formula supply chain response.
Califf said FDA will conduct a competitive national search for a deputy commissioner for human foods who "will have decision-making authority over policy, strategy and regulatory program activities within the Human Foods Program, as well as resource allocation and risk prioritization.”
He also said FDA "has recently formed an Implementation and Change Management Group that will be charged with developing a detailed plan to ensure the successful execution of this vision."
The commissioner said creating a Human Foods Program under a single leader who reports directly to the commissioner “unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way.” A diverse group of stakeholders has repeatedly called on FDA to establish the deputy commissioner position.
An official at FDA familiar with key issues involving the foods program welcomed the strategy laid out by Califf. “From the perspective of those who are committed to modernizing the food safety system, this is good news,” the FDA source told Agri-Pulse.
Califf had multiple internal conversations within FDA as well as with stakeholders before making the announcement. There have been indications that Califf is committed to continue to engage staff on the process, the FDA source added.
The new FDA Human Foods Program would bring under its umbrella the Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR). While details of this proposal continue to be developed, CFSAN, OFPR, and the Office of Regulatory Affairs will continue to operate under their current structures, with the commissioner’s oversight, Califf said.
The proposed plan also creates a Center for Excellence in Nutrition. Califf said this center will prioritize the agency’s efforts to help consumers make informed food choices. It also calls for the establishment of an Office of Integrated Food Safety System Partnerships, which will help more effectively meet the goals of the Food Safety Modernization Act of 2011, including implementation of outstanding rules and guidances.
While the FDA’s Center for Veterinary Medicine (CVM) will continue to operate as a stand-alone center, the relevant food safety activities will be closely coordinated between the CVM director and deputy commissioner for human foods, according to Califf. “This proposed structure will allow CVM to support the Human Foods Program where its activities are relevant to human food safety,” he added.
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In a statement, Roberta Wagner, Consumer Brands Association vice president of regulatory and technical affairs, commended the commissioner for “moving the needle on unified calls to appoint a deputy commissioner for foods to elevate the program’s function and importance and initiate critical culture change and modernization.”
However, Wagner noted that while the announcement is a positive first step, “it fails to provide the deputy commissioner with direct line authority over all major foods program components or fully integrate the agency’s policymakers with its inspection force.” She said CBA is concerned that “anything short of this and a fully empowered deputy commissioner will make it difficult to truly unify the program and deploy the prevention mindset envisioned” under FSMA.
Center for Science in the Public Interest President Peter G. Lurie said in a statement the proposed actions address many of the well-publicized challenges facing the agency’s handling of food safety.
“By elevating the program to be led by a deputy commissioner, streamlining reporting structures, creating a Center for Excellence in Nutrition, and clarifying the relationship between the Office of Regulatory Affairs and the food program, the agency has confronted each of these issues head on in a manner that is likely to improve efficiency and benefit the American people,” he said.
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