Consumer Reports and the National Association of Food and Drug Officials applaud the approval of the FDA’s reorganization plan, saying the move will help ensure the nation’s food supply is safe. “Consumers depend on the FDA to be effectively organized and governed to ensure our food is safe,” Brian Ronholm,… Continue Reading Food Policy & Law, Government Agencies, FDA reorganization, Jim Jones, Robert Califf Food Safety News
Consumer Reports and the National Association of Food and Drug Officials applaud the approval of the FDA’s reorganization plan, saying the move will help ensure the nation’s food supply is safe.
“Consumers depend on the FDA to be effectively organized and governed to ensure our food is safe,” Brian Ronholm, director of food policy at Consumer Reports, said in a news release. “Today’s announcement is a major step forward, and much credit goes to (FDA) Commissioner Robert Califf for facilitating the process to get to this point.
“We recognize that a significant amount of work remains to be done because a meaningful change in culture does not happen overnight. We look forward to working with the FDA to ensure this plan is effectively implemented to carry out its critical mission to protect the public from food safety risks.”
The Association of Food and Drug Officials had similar praise for approving the reorganization efforts.
“We appreciate Commissioner Califf’s commitment to improving the FDA human foods program,” says Steven Mandernach, AFDO Executive Director. “Deputy Commissioner Jim Jones has been engaging and making excellent steps to move the program forward. The approval of the reorganization allows for a much fuller implementation of the vision of the broad human food stakeholder community. We look forward to collaborating with the Deputy Commissioner and his team to help make human foods even safer in the United States.”
With the approval of the plan by the Secretary of the U.S. Department of Health and Human Services, the reorganization of the Food and Drug Administration is set to go into effect on Oct. 1 with the beginning of the federal government’s fiscal year. Reorganizing the agency will impact almost 8,000 employees.
Problems in the structure of the food programs at the Food and Drug Administration came to a head during an outbreak of cronobacter among infants in 2021 and 2022 and the subsequent infant formula crisis of 2022. That crisis saw the recall of much of the infant formula in the United States. The factory that makes the formula was closed for months, causing more shortages.
During a May 2022 congressional hearing, FDA Commissioner Robert Califf was grilled by U.S. House of Representatives members and told to make changes so that internal communication problems brought to light by the infant formula crisis would be resolved.
Those communication problems showed that the lack of a clear chain of command for the food side of the Food and Drug Administration had resulted in delays in identifying the cronobacter outbreak and action to contain it.
Following internal review by the FDA and an external review by the Reagan-Udall Foundation, Califf appointed Jim Jones, a 30-year veteran from the Environmental Protection Agency’s administration, to the new post of FDA Deputy Commissioner for Human Foods. Jones has been working with a team at the FDA to reorganize the agency.
The reorganization includes the creation of new offices, shifting of responsibilities from one office to another, and the consolidation of other programs within the FDA superstructure.
According to a statement from the FDA announcing final approval of the reorganization plan, the changes “will enable the FDA to be more efficient, nimble and prepared for the ever-changing and complex industries we regulate, new food and medical product technologies, as well as the impacts of globalization, climate change and other factors that require the agency to adapt quickly.”
The FDA commissioner, Dr. Robert Califf, said the reorganization will make the agency more efficient and work more collaboratively.
“This is a distinctive moment for the FDA. I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall,” Commissioner Califf said in the announcement.
The creation of a unified Human Foods Program will allow the agency to more effectively realize the preventive vision laid out in the Food Safety Modernization Act, elevate the importance of nutrition, strengthen local, state, and international partnerships, and position the FDA to regulate innovative food and agricultural products more effectively, according to the agency’s statement.
In addition, the agency will be better positioned to uphold the safety of the nation’s food supply and respond to food-related emergencies, such as the 2022 infant formula shortages.
The reorganization established the Human Foods Program by revising the Center for Food Safety and Applied Nutrition functions, the Office of Food Policy and Response, and key functions from the Office of Regulatory Affairs (ORA) under one program.
Additionally, the restructuring of ORA will enable the FDA’s field operations unit to focus on inspections, investigations, and imports. According to the agency’s announcement, the FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA.
The reorganization includes:
Making the FDA’s Human Foods Program and product centers solely responsible for receipt, triage, and closing consumer and whistleblower complaints, rather than this role being split between centers and field offices.
Renaming the Office of Regulatory Affairs (ORA) as the Office of Inspections and Investigations (OII) and solidifying its role as the frontline of the FDA’s field-based inspection, investigation, and import operations.
Establishing an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues, including special populations such as children and people with rare diseases. This includes a new Office of Public Health Preparedness and Response to support medical countermeasure policy, emergency preparedness work, and medical product shortage coordination across the agency.
Merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) to form a new office; both offices are currently housed within the FDA’s Office of the Chief Scientist (OCS). This newly merged office in OCS, proposed as the Office of Regulatory and Emerging Science, will strengthen the support of regulatory science and preparedness research efforts.
Creating an Office of Enterprise Transformation. This proposed new office in the Office of the Commissioner will work across the FDA to drive high-priority cross-cutting business process improvement efforts. The proposed shift will result in more strategic and efficient use of agency resources,
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