FDA Provides Update on External Evaluation to Strengthen Agency's Human Foods Program

The following is attributed to FDA Commissioner Robert M. Califf, M.D.

SILVER SPRING, Md., Dec. 6, 2022 /PRNewswire/ -- In July, I commissioned an external evaluation of the U.S. Food and Drug Administration's Human Foods Program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). The external evaluation, conducted by an expert panel facilitated by the Reagan-Udall Foundation, was asked to assess the processes and procedures, resourcing, and organizational structure for the Foods Program.

Today, the panel released its findings and recommendations to the agency. I want to thank the panel and the Reagan-Udall Foundation for their work and for all those, including FDA staff and external stakeholders, who provided important feedback for the panel to consider. Although we have not yet had an opportunity to review the full report in depth, it does provide significant observations and options for the agency's consideration, reflecting important and diverse perspectives, which will be carefully considered.

The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program. 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. This new vision and structure will be built on the external evaluation being released today; the internal review of the agency's infant formula supply chain response completed in September, which has already resulted in noticeable improvements in our operations across the Foods Program; and ongoing work that allows the agency to take advantage of emerging advances in food science, with a goal of designing a system that allows us to more quickly adapt to an ever-changing and evolving environment.

I will be making final decisions regarding the future of the FDA Human Foods Program after reviewing the report and consulting with stakeholders both externally and internally. To assist me in this effort, I am forming a group of agency leaders to advise me on how best to implement and operationalize these findings. I expect this leadership group to be bold and focused on the transformative opportunities ahead for the FDA's food program – by fully realizing the preventive vision laid out in the Food Safety Modernization Act, elevating the importance of nutrition given declining life expectancy in the U.S., due in large part to chronic diseases, strengthening our state partnerships, and embracing innovative food and agricultural technologies that will allow us to supply the nation – and the globe – with ample safe and nutritious food in the decades ahead. 

I will closely oversee the Human Foods Program until a determination is made on how we will strengthen and modernize the program. I will be fully engaged to ensure that the program comes out of this transition with the resources, tools and visibility it warrants given how critical its work is to every American. 

The Human Foods Program is a top priority for the agency. America's food supply is as safe as it's ever been, and our Foods Program experts have significantly contributed to the availability of more safe and nutritious food options for consumers. That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation's food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today.

Each of these factors point to the need to evolve our existing Foods Program leadership and structure and identify new ways to fund these mission critical activities. In addition, the agency's inspectional activities, including those conducted in collaboration with our state and international partners, are critical in order to assure a safe and high-quality food supply. And finally, the need to maintain upgraded digital technology systems that allow us to stay ahead of the vast and growing food system, are essential components of any future plan.

I am fully committed to building a world-class Human Foods Program that works best for the public, our stakeholders and our employees – and that will allow us to effectively deliver on our mission.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration