For immediate release:
Declaration of :

Robert M. Califf, MD, MACC
Food and Drug Commissioner – Food and Drug Administration

In February 2022, I joined the United States Food and Drug Administration as Food and Drug Commissioner, having served in that role five years earlier. Since my return, the agency has taken many important steps that benefit public health. Yet, at the same time, the agency has faced a series of challenges that have tested our regulatory frameworks and tested agency operations, prompting me to examine closer to our way of doing business.

Accordingly, for two of the agency’s key programs, I commissioned external experts from the agency to conduct a comprehensive assessment to:

The agency’s human food program, including the Office of Food Response and Policy (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parties from the Office of Regulatory Affairs ( ORA)

Although the U.S. food supply is secure and our Foods program experts have contributed significantly to making more nutritious food options available to consumers, the program has been challenged by the growing diversity and complexity of the country’s food and supply chain systems. Fundamental questions about structure, function, funding and leadership need to be addressed. Agency inspection activities related to the program should also be assessed, particularly in light of the constraints related to the COVID-19 pandemic.

The Center for Tobacco Products (CTP)

Just over 13 years ago, Congress appointed the FDA to regulate tobacco products. In the years that followed, we made significant progress and regulatory decisions on a wide range of millions of products. But even greater challenges lie ahead as we determine how the agency will handle complex policy issues and determine enforcement activities for a growing number of new products that could have significant public health consequences. The CTP will continue its important work during the assessment, including reviewing pending requests and taking enforcement action if necessary.

I have discussed this assessment with the relevant leaders of these centers and offices, all of whom welcome the opportunity to work towards organizational excellence. Each of these fields is full of hardworking and talented individuals who have dedicated their careers to working in a variety of scientific, political, legal and administrative pursuits. FDA employees deserve the best possible support so they can fulfill their strong commitment to public health — and the American public we serve.

The Reagan Udall Foundation, an independent partner organization of the agency, will work with an external group of experts on the evaluation. The Foundation will report its findings, including an initial assessment of Foods Program and CTP processes and procedures, resources, and organizational structure, to the agency within 60 working days of launch. It may take some time to implement the recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner. I am confident that this effort will continue to strengthen the FDA and better position the agency to address the many immediate public health issues we face, while preparing for the many scientific challenges and fascinating opportunities of the future.

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Master key

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.