As the nation’s oldest comprehensive consumer protection agency, the U.S. Food and Drug Administration has been responsible for ensuring the safety of foods consumed by hundreds of millions of Americans every day while advancing nutrition for more than a century. It is our mission to ensure that our programs are organized in a way that protects and promotes public health.

The agency carefully reviewed the findings and recommendations of an external assessment I requested, conducted by a panel of experts from the Reagan-Udall Foundation, as well as a separate internal review of the agency’s response to the infant formula supply chain, completed last year. The findings and recommendations from these reviews identified issues related to culture, structure, resources, and authority. They also identified several areas of need, including modernizing data systems, providing more resources and authorities, improving emergency response systems, and building a more robust regulatory program.

Today I’m announcing a new, transformative vision for the FDA Human Foods Program. I’m also announcing a transformative vision for the Office of Regulatory Affairs (ORA, the FDA’s field-based operations) to support the FDA organization as a whole. The proposed structures for both groups will have clear priorities focused on protecting and promoting a safe, nutritious U.S. food supply that adapts more quickly to an ever-changing and evolving environment. I believe this proposed approach takes into account the recommendations set out in both reports and takes into account feedback from stakeholders as well as the voices of staff working in the Human Foods program who have had the opportunity to share in numerous interactive and listening sessions in the past Month. The creation of a human nutrition program under a single leader reporting directly to the Commissioner unifies and enhances the program while eliminating redundancies, allowing the agency to oversee human nutrition more effectively and efficiently.

Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of ORA will be combined into a newly proposed organization called the Human Foods Program. The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods to oversee the program. The person in this position will report directly to me and will be tasked with leading a unified human nutrition program that keeps the foods we regulate safe and nutritious while ensuring the agency is kept up-to-date with the latest advances in science, technology and… Technology is nutrition. The Deputy Commissioner has decision-making authority over the policy, strategic and regulatory program activities within the Human Foods program, as well as resource allocation and risk prioritization. Other key elements of the proposed new organization of the Human Feeding Program are:

• Creation of a Center for Excellence in Nutrition that will prioritize the agency’s ongoing efforts to help American consumers make more informed food choices, including by collaborating with the industry to provide healthier, more nutritious food products. The FDA is proposing to establish a Critical Foods Office within this center as required by the Consolidated Appropriations Act of 2023.
• Established an Office of Integrated Food Safety Systems Partnerships that will focus on improving, coordinating, and integrating our food safety and response activities with state and local regulatory partners to more effectively implement the vision of an integrated food safety system as envisioned in FDA Food Safety to comply with Modernization Act of 2011. This newly proposed structure will ensure greater cooperation and support of state-level inspection activities. We know we can’t be everywhere, and going forward, our relationships with our state and local regulatory partners will be more important than ever.

An Advisory Committee on Human Foods will be established to support the Agency’s science-based decision-making activities. Advisory committees are typically set up to seek independent expert advice on various issues. The Human Foods Advisory Committee will consist of external experts who will advise on challenging and emerging issues in the fields of food safety, nutrition and innovative food technologies.

Finally, a focus will be on strengthening our corporate information technology and analytics capabilities to deliver on the promise outlined in the new era of smart food safety and to support the workflow improvements that will accompany these changes. This focus area will support the work of the Human Foods program by enabling easier communication, more efficient operations and improved empirical risk algorithms to guide program priorities and work in this area.

As part of this proposed new vision, ORA’s operational structure will be transformed into an enterprise-wide organization that supports the Human Foods Program and all of FDA’s other regulatory programs (e.g. agency centers) by focusing on their critical activities. This realignment will allow ORA to focus solely on excellence in its core mission – inspections, laboratory testing, import and investigative activities. This streamlines ORA’s operations in alignment with FDA’s public health and prevention goals. Certain other functions of ORA are being aligned in other parts of the FDA to create an overall stronger agency.

While the FDA’s Center for Veterinary Medicine (CVM) will continue to operate as a standalone center, relevant food safety activities will be closely coordinated between the Director of the CVM Center and the Deputy Commissioner for Human Nutrition. This proposed structure will allow CVM to support the Human Foods Program where its activities are relevant to human food safety.

The FDA recently formed an implementation and change management group tasked with developing a detailed plan to ensure the successful implementation of this vision.

Consumers can be confident in the safety of the foods they eat every day, thanks in part to the work of FDA’s dedicated staff. Our ability to continue our work means constantly evolving and adapting to the ever-changing, complex industries we regulate and the emergence of new technologies. As a next step, the FDA must develop the vision announced today into a concrete reorganization proposal in close coordination and communication with internal and external stakeholders, while ensuring that we meet our labor law obligations. While the details of this proposal continue to be developed, CFSAN, ORA and OFPR will continue to operate under their current structures under my direct supervision. I look forward to providing further public updates on our progress, organizational design and timeline by the end of February.

###

---