Consumer Reports magazine and the National Association of Food and Drug Administration officials praised the FDA’s approval of the reorganization plan, saying the move will help ensure the safety of the nation’s food supply.
“Consumers expect the FDA to be effectively organized and regulated to ensure food safety,” Brian Ronholm, food policy director at Consumer Reports, said in a news release. “Today’s announcement is a major step forward, and we give great credit to (FDA) Commissioner Robert Califf for accelerating the process to this point.”
“We recognize that meaningful cultural change doesn’t happen overnight, and there is much work still to be done. We look forward to working with the FDA to ensure this plan is implemented effectively to fulfill our important mission of protecting the public from food safety risks.”
The Food and Drug Administration Association similarly praised the approval of the restructuring effort.
“We appreciate Commissioner Califf’s commitment to improving FDA’s food program,” said AFDO Executive Director Steven Mandernak. “Deputy Commissioner Jim Jones has been proactive and taking great steps to move the program forward. With the restructuring approved, we will be able to more fully realize the vision of the broad food stakeholder community. We look forward to working with the Deputy Commissioner and his team to further advance food safety in the United States.”
With the U.S. Secretary of Health and Human Services approving the plan, the Food and Drug Administration reorganization will take effect on Oct. 1, the start of the federal government’s fiscal year. The agency’s restructuring will affect roughly 8,000 employees.
Structural problems with the Food and Drug Administration’s food program came to a head during the Cronobacter outbreaks among infants in 2021 and 2022, followed by the infant formula crisis in 2022. The crisis led to the recall of much of the infant formula in the U.S. Plants that make formula were closed for months, causing further shortages.
During a congressional hearing in May 2022, FDA Commissioner Robert Califf was grilled by members of the U.S. House of Representatives and ordered to make changes to address internal communication issues exposed by the infant formula crisis.
These communication problems suggest that a lack of a clear chain of command within the Food and Drug Administration’s food division delayed steps to identify and contain the Cronobacter outbreak.
Following an internal FDA investigation and an external investigation by the Reagan-Udall Foundation, Administrator Califf appointed Jim Jones, a 30-year veteran of the Environmental Protection Agency Administration, to the new position of Deputy Administrator for Human Foods at the FDA, where he is working with his FDA team to restructure the agency.
The reorganization includes the creation of new offices, the transfer of responsibilities from one office to another, and the consolidation of other programs within FDA’s umbrella organization.
According to an FDA statement announcing final approval of the reorganization plan, the changes will “allow the FDA to be more efficient, agile, and prepared to respond to the ever-changing and complex industries it regulates, new food and drug technologies, and the effects of globalization, climate change, and other forces that require the agency to adapt quickly.”
FDA Commissioner Dr. Robert Califf said the reorganization will make the agency more efficient and enable it to work more collaboratively.
“This is an extraordinary moment for FDA. After a year and a half of painstaking work and effort on this transformative vision for FDA’s human food programs and agency structure, I am incredibly pleased that we are one step closer to seeing the largest agency reorganization in recent history become a reality this fall,” Commissioner Califf said in the announcement.
According to a statement from the FDA, the creation of the Uniform Human Food Program will enable the FDA to more effectively implement the prevention vision set out in the Food Safety Modernization Act, elevate the importance of nutrition, strengthen local, state and international partnerships, and position the agency to more effectively regulate innovative foods and agricultural products.
Additionally, the agency will be better positioned to maintain the security of the nation’s food supply and respond to food-related emergencies, such as the 2022 infant formula shortage.
This reorganization established the Human Food Program by combining the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy Response, and key functions of the Office of Regulatory Affairs (ORA) into one program.
Additionally, the restructuring of ORA will allow the FDA’s field operations division to focus on inspections, investigations, and imports. According to an FDA announcement, the FDA will change the name of ORA to the Office of Inspection and Investigations (OII) to more clearly communicate the organization’s role as the FDA’s front line.
The restructuring includes:
Give FDA’s Center for Human Food Programs and Products sole responsibility for receiving, triaging, and closing consumer and whistleblower complaints, and avoid splitting this role between centers and field offices. Rename the Office of Regulatory Affairs (ORA) to the Office of Inspections and Investigations (OII) to strengthen its role as the front line for FDA’s field inspections, investigations, and import operations. Establish an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of medical issues across agencies, including special populations such as children and rare disease patients. This includes a new Office of Public Health Preparedness and Response to support medical countermeasures policy, emergency preparedness efforts, and medical product shortage coordination across the agency. Combine the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) to form a new office. Currently, both offices are located within FDA’s Office of the Chief Scientist (OCS). This newly consolidated office within OCS is proposed as the Office of Regulatory and Emerging Science, which will provide enhanced support for regulatory science and preparedness research activities. Create an Office of Corporate Transformation. This new office, proposed for the Commissioner’s Office, will operate across FDA and drive high-priority, cross-cutting business process improvement activities. The proposed transition will result in a more strategic and efficient use of agency resources. (Click here to sign up for a free subscription to food safety news.)
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