Expert Panel Issues Report on FDA Tobacco Regulatory Operations

On July 19, 2022, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf issued a public statement directing the Reagan-Udall Foundation to engage an independent expert panel to evaluate the operational aspects of the FDA’s tobacco regulatory program. In the statement, Commissioner Califf stated that “the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.” The expert panel selected by the Reagan-Udall Foundation was comprised of former FDA leaders and regulatory strategist as well as process improvement specialists.

The expert panel did not review the actual tobacco-related policies put forth by the FDA’s Center for Tobacco Products (CTP), but rather carried out an evaluation process that focused on how the agency operates regarding the proposal and adoption of regulations and guidance, product application review, compliance and enforcement, and communication with the public and other stakeholders.

In December of 2022, the expert panel issued its report titled “Operational Evaluation of Certain Components of FDA’s Tobacco Program.” Click here for more information on the report.