TOP TAKEAWAYS
- The review seeks to elevate the prominence of the FDA’s Human Food Programs as opposed to its drug/medical device functions
- Funding for food programs, including food safety, has lagged in other areas
- The Consumer Brands Association supports many of the report’s recommendations
A review of the Food and Drug Administration’s Human Food Program has called for an increased focus on food safety and structural changes that could help distinguish the FDA’s food-related functions from other responsibilities, such as drugs and medical devices.
In its report, the Reagan-Udall Foundation suggested that the Human Food Program at the FDA has been underfunded and that it could be better organized with a single leader overseeing all food-related functions at the agency.
“The current organizational structure lacks a clear leader and decision maker,” the report concluded.
It outlined several options for overhauling the structure of the FDA to bring greater emphasis onto human food oversight. Each of the alternatives would also create a new Center for Nutrition and would seek to better integrate portions of the Office of Regulatory Affairs (ORA) into food program centers.
One of the proposed options for revamping the structure of the FDA would involve splitting the FDA into two divisions—a Federal Drug Administration and a Federal Food Administration—each of which would have its own commissioner, both of whom would report to the Health and Human Services commissioner.
Another option calls for creating two deputy commissioners within the FDA, one overseeing medical products and tobacco, and the other overseeing food.
The report also detailed how funding increases for Human Food Programs at the FDA have lagged other funding increases for other areas, and suggested increases in industry fees as authorized in the Food Safety Modernization Act or “additional mechanisms for industry support” of the Human Foods Program.
“States have a long history of assessing annual fees to facilities registered in their states. Such an approach may be feasible at the federal level,” the report explained.
Among the report’s other recommendations:
- A new Foods Advisory Committee, at the commissioner-level, should be established to strengthen external input to Human Foods Program activities. The report noted that a former Foods Advisory Committee advising the FDA’s Center for Food Safety and Applied Nutrition was disbanded in 2017, but the new committee would elevate its stature
- The FDA should leverage the 21st Century Cures Act to improve its ability to recruit, hire and retain personnel with the skills needed to effectively meet its public health mandate around food. “Given ongoing advancements in science and technology, the Human Foods Program urgently needs these hiring and salary authorities,” the report concluded
- The FDA should move to a stronger, more cooperative relationship with states and other local authorities in order to expand its ability to use state and local resources
The report also touched on areas including data sharing, food recalls, nutritional labeling and preventative controls for food safety.
“The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program,” said FDA Commissioner Robert M. Califf, in a statement.
He said the FDSA would provide an update on its plans going forward by the end of January 2023 and additional updates by the end of February, including the planned leadership structure and any changes to key internal processes and procedures.
“We appreciate the Reagan-Udall Foundation’s work to address the structural, governance and leadership issues plaguing FDA’s food program,” said Roberta Wagner, VP of regulatory and technical affairs at the Consumer Brands Association, in a statement.
Many of the actions called for in the report reflect the CBA’s recommendations, including centralizing authority under a deputy commissioner of foods directly overseeing all food program components. The report also mirrored CBA’s call for a “culture shift” at the FDA and a new inspection paradigm “to make FDA’s food program more effective and aligned with the prevention-oriented focus of the bipartisan Food Safety Modernization Act.”