Expert Panel Submits Operational Evaluation of FDA’s Tobacco Program to Commissioner

Report posted on the Reagan-Udall Foundation website 

(December 19, 2022) The Independent Expert Panel for Tobacco today submitted its recommendations to Commissioner Robert Califf at the U.S. Food and Drug Administration. The Operational Evaluation of Certain Components of FDA’s Tobacco Program was facilitated by the Reagan-Udall Foundation at the Commissioner’s request. 

The Panel was comprised of former federal public health leaders, regulatory strategists, and process improvement specialists. Lauren Silvis, JD, served as Chair of the Panel, which included Jane Axelrad, JD; Keith Flanagan, JD; Charlene Frizzera; and Alberto Gutierrez, PhD. 

“The Panel provided recommendations to help the Agency’s tobacco program strengthen its operations as it works to reduce the harm associated with tobacco use,” said Lauren Silvis, JD, who chaired the Expert Panel. “The Center for Tobacco Products has made significant progress in establishing a regulatory program for tobacco products and our recommendations are intended to help the Center develop additional tools for achieving its public health objectives.”   

Through multiple listening sessions, interviews, and an online portal, the Panel received and carefully reviewed input from a range of stakeholders, including FDA staff and the public. The Report offers cross-cutting and program-specific recommendations for the Commissioner to consider, focusing on regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. The Panel did not address tobacco policy issues, which are outside the scope of this evaluation. 

The report is posted at

About the Reagan-Udall Foundation for the FDA

The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.

Media Contacts:

Lea Ann Browning-McNee
301-509-1846 (cell)  

Mary McNamara
202-276-7822 (cell)