Announcing a new Human Foods Program at FDA - a first look at key components

FDA has announced a restructuring of the human foods program in response to the findings and recommendations in the Reagan-Udall Foundation’s Operational Evaluation of FDA's Human Foods Program issued on December 6, 2022.

The new structure seeks to unify many elements in the agency that oversee the human food supply, enhance coordination with the field operational component, and elevate the importance of nutrition at the agency. The reorganization combines the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA) into a newly named “Human Foods Program.”

Leadership

The Human Foods Program will be led by an “empowered” Deputy Commissioner for Human Foods, who will establish executive leadership and strategic direction over the entire portfolio of human foods, including resource allocation, risk prioritization, strategy, and an integrated food safety partnership programs with state and local partners. In addition, a larger executive team with clear roles and responsibilities will be put in place to improve FDA’s decision making on key issues and provide strong, effective operational management of the program’s day-to-day operations.

Other key components

Other key components of the new structure include:

• A new Center for Excellence in Nutrition with oversight over nutrition science, policy, and initiatives to reduce-diet-related chronic diseases and improve health equity. Within that Center will be an Office of Critical Foods that will oversee infant formula and medical foods established, in part, as a response to the recent infant formula crisis.
• An Office of Integrated Food Safety System Partnership (formerly part of ORA) to prioritize and unify the FDA’s work with state and local regulators.
• A Human Foods Advisory Committee, which will provide access to external experts on challenging and emerging issues in food safety, nutrition, and innovative food technologies.

In its announcement, the agency reiterated its commitment to the modernization goals in the New Era of Smarter Food Safety initiative, which envisions leveraging technology and other tools and approaches to create a safer and more digital, traceable food system.

In addition to these changes, the agency announced changes at the Center for Veterinary Medicine (CVM) – which will remain an independent Center – to enhance collaboration with the Human Foods Program. These include the creation of an Office of Animal Biotechnology Innovation in CVM to advance the FDA’s regulation of animal and agricultural biotechnology. In addition, there will be an expanded role of the CVM Director to include duties of Chief Veterinary Officer (CVO) to strengthen CVM's One Health role and the connections between animal and human foods on issues that have implications for human, environmental, and animal health.

In contrast to recommendations in the Reagan-Udall report, the new structure does not fully align ORA’s food activities into the Human Foods Program Structure and, therefore places several components outside the line authority of the Deputy Commissioner for Human Foods. While the agency clarifies that ORA’s goals around risk prioritization and public health impact will be determined by the regulatory programs, it leaves inspections, investigations, laboratory analysis, and import operations in the current ORA structure.

Unanswered questions, implementation concerns

While many of these changes will be welcome, there are still many unanswered questions. For example, there is no mention of where dietary supplements or cosmetics (both currently housed within CFSAN) will be placed, nor are there specifics about how these changes will impact ORA’s Office of Human and Animal Food Operations, including what will happen to FDA’s retail programs. The agency has stated that a new Implementation and Change Management Group will be charged with developing a more detailed plan to execute the reorganization so we should expect additional information in the future.

Perhaps the two biggest implementation issues are time and resources. Past experience tells us that any reorganization takes time and it will be years before any realignment is truly in effect. Moreover, wherever you move the pieces, the Human Foods Program needs funding and the ability to hire and retain needed expertise. Significantly, there are no details about how FDA’s limited resources will be allocated across this new structure or how resources might be increased in the future. Without adequate resources, many of the problems with the foods program will remain.

Learn more about the implications of this new structure by contacting the author or your usual DLA Piper relationship attorney.