FDA Commissioner Announces New Vision for Human Foods Program

Based on data and recommendations from an external review by the Reagan-Udall Foundation and the results of an internal study, FDA commissioner Robert M. Califf, MD, MACC, announced a new vision for the Human Foods Program. The concept includes plans to redesign the current prevention and response strategies.

The external and internal reviews identified multiple issues with the current culture, structure, resources, data systems, emergency response systems, regulatory programs, and more in the existing systems.

As part of the recommendations proposed, the Reagan-Udall foundation has suggested an update to the Human Foods Program mission, vision, and value statement to deliver a clear and compelling goal. Additional culture-related suggestions included establishing clear leadership, supporting a culture rooted in scientific evidence for making regulatory changes, transparency, and more.

Structural recommendations included enhancing the program’s visibility and prominence, making it comparable to the reputation of the medical products program by the FDA. Other structural actions include developing a clear line of authority, focusing more on the importance of nutrition, and integrating the office of regulatory affairs.

Additional examples of favorable change include developing stronger relationships with local and state authorities, expanding staff engagement in outside conferences, providing increased financial support to the program, and amending current reporting strategies.

Based on these recommendations, an evaluation of the FDA’s response to infant formula supply chain issues, and more, Claiff has proposed a plan for increased collaboration and support from the Office of Regulatory Affairs (ORA).

“I believe this proposed approach addresses the recommendations outlined in both reports, and considers feedback from stakeholders, as well as the voices of employees working in the Human Foods Program who had an opportunity to share input through numerous interactive and listening sessions over the past month. Creating a Human Foods Program under a single leader who reports directly to the Commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way,” he stated in the press announcement.

Plans include combined efforts and functions from the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and the ORA to create a new and improved Human Foods Program. The effort will be headed by the Deputy Commissioner for Human Foods, which the FDA seeks to recruit.

Additional plans include improving consumer education on food choices, offering healthier food products, coordinating food safety and response activities across multiple regulatory levels, and enhancing analytical capabilities across the program.

“Our ability to continue our work means consistently evolving and adapting with the constantly changing, complex industries we regulate and the emergence of new technologies. As a next step, the FDA will need to develop the vision announced today into a concrete reorganizational proposal in close coordination and communication with internal and external stakeholders while ensuring we meet our labor obligations. While details of this proposal continue to be developed, CFSAN, ORA, and OFPR will continue to operate under their current structures, with my direct oversight. I look forward to providing additional public updates by the end of February on our progress, organizational design, and timeline,” concluded the commissioner in his announcement.