Industry sees 'significant steps' with FDA reforms

For more than a century the U.S. Food & Drug Administration has been responsible for ensuring the safety of food products consumed by hundreds of millions of Americans each day while also advancing nutrition. After reviewing the findings and recommendations from external and internal reviews, the FDA identified issues surrounding culture, structure, resources and authorities, as well as several areas of need.

"Today I am announcing a new, transformative vision for the FDA Human Foods Program," said Robert M. Califf, commissioner of food and drugs at the Food & Drug Administration. "I am 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 that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment. "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," said Califf.

The International Fresh Produce Association welcomed the announcement by Califf and said it anxiously awaits additional details .

“The changes proposed today represent significant steps in the right direction. The vision laid out by the commissioner is likely to streamline decision-making within the agency,” said Jennifer McEntire, IFPAs chief food safety and regulatory officer. “The parts of FDA that produce industry members interact most closely with — inspectors, regulatory labs and import operations, will still be managed separately within the Office of Regulatory Affairs, necessitating strong, collaborative leadership between the new deputy commissioner and ORA.

“Continued stakeholder engagement is critical as details regarding the relationship between the Human Foods Program and ORA are refined, and to ensure the new structure sets the agency up for success through changes in leadership,” said McEntire. “It’s critical that the new structure eliminates silos and fosters a prevention-oriented culture.”  

“Western Growers applauds the Food & Drug Administration commissioner and senior leadership for taking these first important steps to strengthen the Human Foods Program," said Western Growers Senior Vice President of Science De Ann Davis. "We appreciate the commissioner’s consideration of the recommendations of the independent expert panel convened by the Regan-Udall Foundation, as well as the voices of many diverse but united stakeholders in the need to improve the program’s culture of prevention, responsiveness and transparency. The fresh produce supply chain needs a strong and engaged FDA to support our nation’s growers and their commitment to continuous improvement of safety, affordability and accessibility of these highly nutritious foods."

Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a newly envisioned organization called the Human Foods Program.

Key elements of the proposed new Human Foods Program organization include the creation of a Center for Excellence in Nutrition that prioritizes the agency’s ongoing efforts to help American consumers make more informed food choices, including by working with industry to offer healthier, more nutritious food products. The FDA proposes to establish an Office of Critical Foods, as directed by the 2023 Consolidated Appropriations Act, within this center. 

It also includes the establishment of an Office of Integrated Food Safety System Partnerships that will focus on elevating, coordinating and integrating our food safety and response activities with state and local regulatory partners to more effectively meet the vision of an Integrated Food Safety System as envisioned in the FDA Food Safety Modernization Act of 2011. This newly proposed structure will ensure greater collaboration and support of state-level inspectional activities. We know that we cannot be everywhere, at all times, and our relationships with our state and local regulatory partners will be more important than ever going forward.

To help support the agency’s scientifically grounded decision-making activities, a Human Foods Advisory Committee will be established. Advisory committees are commonly used to obtain independent expert advice on various issues. The Human Foods Advisory Committee will consist of external experts to advise on challenging and emerging issues in food safety, nutrition and innovative food technologies.

Finally, there will be an emphasis on strengthening enterprise information technology and analytical capabilities to fulfill the promise described in the New Era of Smarter Food Safety and support the improvement in workflow that will accompany these changes. This area of focus will support the work of the Human Foods Program by enabling more facile communication, more efficient operations and enhanced empirical risk algorithms to guide the priorities of the program and the work in the field.

As part of this proposed new vision, ORA’s operating structure will be transformed into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs by focusing on its critical activities. This realignment will allow ORA to be singularly focused on excellence in its core mission – inspections, laboratory testing, import and investigative operations. This will optimize ORA’s operations in line with the FDA’s public health and prevention-oriented goals. Certain other functions of ORA will be aligned in other parts of the FDA to create an overall stronger agency.