On July 19, 2022, FDA Commissioner Robert Califf published a statement regarding FDA’s evaluation of agency activities. In his statement, Califf acknowledged that the agency has recently confronted challenges that have tested its regulatory frameworks. As a result, Califf commissioned external agency experts to conduct evaluations for the agency’s Human Foods Program and Center for Tobacco Products.

The evaluation of the Human Foods Program will include the Office of Food Response and Policy (OFPR), Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). Califf noted that the program has been stressed by complexity of the nation’s food systems and supply chain, and that fundamental questions regarding the structure, funding and leadership of the program must be addressed. The evaluation of the Center for Tobacco Products (CTP) will focus on how the agency will address policy issues and enforcement activities for an increasing number of novel products.

The Reagan-Udall Foundation, an independent partner organization for FDA, will work with the external group of experts on the evaluation and will report its findings to FDA within 60 days of initiation. Califf stated that he was committed to addressing the findings and communicating them to the public and believes that the evaluation will support the agency in addressing immediate and future public health matters.