Report offers options for FDA food program reorganization

The Food and Drug Administration Human Foods Program needs a single leader and a clear mission and vision to overcome recent problems including the unexpected shortage of infant formula, an outside expert panel said in a report issued today, Dec. 7, but the panel offered options for changing the structure of the agency rather than a single strong set of recommendations.
The panel, assembled by the public-private Reagan-Udall Foundation, said the FDA’s placement of authority for human foods into three separate divisions plus some other authorities in other divisions not covered by the report has made the agency less than an effective regulator in the food area. The problems include indecisiveness, inaction and disincentives for collaboration, the panel said.
But rather than reaching a strong conclusion on how the FDA’s Human Foods Program should be organized, the panel offered five options for reorganization:
▪ Separate food and drugs within the Health and Human Service Department by creating a Federal Food Administration that is separate from a Federal Drug Administration, each with a commissioner reporting directly to the HHS secretary.
▪ Create both a deputy commissioner of foods and a deputy commissioner for medical products and tobacco, each with line authority over respective centers, and establish a chief foods officer within the Office of the Commissioner.
▪ Establish the Center for Food Safety and Applied Nutrition as the overall lead for the FDA Human Foods Program and establish a chief foods officer or deputy chief of staff for foods within the Office of the Commissioner.
▪ Establish the Food and Drug Administration commissioner as the leader of the Human Foods Program on the assumption that the commissioner will “actively engage in and embrace the Human Foods Program responsibilities” and establish a chief foods officer within the Office of the Commissioner.
▪ Create a deputy commissioner for foods with line authority over the Human Foods Program and decrease direct reporting from other officials to the commissioner. This structure does not include the creation of a deputy commissioner for medical products and tobacco. This approach “likely will not require explicit congressional approval; it may require congressional notification,” the report says.

The report also says the FDA needs more flexible hiring authority and a bigger budget, possibly through the establishment of more user fees. The report noted that there is “significant skepticism in the public interest community about the potential for ‘industry capture’ of the Human Foods Program if FDA is overly reliant on industry fees. Efforts to establish structures to secure additional industry funding, such as enhanced registration fees, may address these concerns. While the panel acknowledges these concerns, the panel recommends that FDA explore whether common ground can be found on this issue.”
The panel also said that “the importance of nutrition should be elevated” with the creation of a new Center for Nutrition that would address the interdependence of nutrition and food safety.
FDA Commissioner Robert Califf in a statement today noted that the foundation had established the panel at his request and said it provides “significant observations and options for the agency’s consideration.”
“The agency is committed to providing a public update on the new vision at the end of January 2023 and additional public updates by the end of February 2023, including the planned leadership structure and any changes to key internal processes and procedures,” Califf said.
Brian Ronholm, director of food policy for Consumer Reports, said, “Today’s report is a very encouraging first step that will hopefully translate into meaningful reform within the FDA foods program. We cannot afford to tolerate the status quo and let this moment go by without adopting fundamental changes to improve the FDA’s ability to protect the public and ensure our food is safe.”
Ronholm continued, “We need strengthened leadership and accountability at the FDA to implement a culture of prevention, respond more quickly to problems as they arise, and take timely action on proposed food safety rules and initiatives. The FDA needs an empowered leader to ensure that all of the agency’s food program staff work together seamlessly with a common strategic direction, clear priorities, sound resource management, and internal accountability.”
The Alliance for a Stronger FDA, which is composed of 160 stakeholder organizations that advocate for FDA to have resources commensurate with its growing responsibilities, thanked the panel for its efforts and said, “Reform and increased resources are necessary complements: Money without reform will fail, but reform without money will also fail.”
The alliance added, “Old programs, though inadequate, will need to be maintained while new structures, new programs, and new leadership is put in place. That’s impossible to do within the current funding.”
Center for Science in the Public Interest President Peter Lurie said the panel issued “a comprehensive report that identifies what ails the food program from leadership to culture to resources.”
“It appropriately argues for greater emphasis on nutrition in a program that has historically not emphasized this sufficiently. It captures the organizational dysfunction at the top of the foods program, but punts the question of organizational structure to Commissioner Califf,” Lurie said.
“That is fine for now; but ultimately no structure can solve these problems until the underlying cultural issues are addressed.”
De Ann Davis, senior vice president for science at Western Growers, which represents fruit and vegetable growers in California, Arizona, Colorado and New Mexico, said, “We are very pleased and thankful for the expert panel’s dedication to this report. We think it reflects many of the conversations that we’ve had and recommendations that we made, including the need for a single point of leadership for the agency when it comes to human foods program.
“We are also appreciative of the panel’s acknowledgement of the need for a prevention focus by the agency when it comes to the safety of the nation’s food,” Davis said.
This was the original intention of the Food Safety Modernization Act, and we are very grateful for the call to see it re-established. With more than 20,000 farms in California alone that provide produce to the nation, we acknowledge that the best way to continue to achieve food safety is through prevention-based programs rather than compliance.”
Joseph Scimeca, senior vice president of regulatory and scientific affairs for the International Dairy Foods Association, noted that IDFA and other food industry organizations and non-governmental organizations had called for the creation of a a deputy commissioner for foods.
But Scimeca also said, “Other areas of the report call for strengthening the use of existing authority or raising new authorities, with recommendations made for increased resources.”
“On new or increased authorities, IDFA urges caution and believes efforts to seek incremental funding should only be based on clearly identifiable operational gaps and/or regulatory activities that are directly tied to the advancement of public health and only when the FDA’s budget expenditures for the food program are fully transparent,” Scimeca said.
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