By Timothy S. Donahue
Top Takeaways:
- Leadership Change: Jessica Zeller takes over tobacco compliance and enforcement Nov. 1.
- Familiar Face: She previously served as the office’s inaugural deputy director.
- Industry Experience: Zeller returns after overseeing regulatory and compliance matters at Edwards Lifesciences.
Jessica Zeller is returning to familiar territory at the FDA, but this time she’s getting the top job.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) announced that Zeller will become director of its Office of Compliance and Enforcement on Nov. 1, returning to an office where she previously served as inaugural deputy director.
Zeller joins CTP from Edwards Lifesciences, a medical-device manufacturer, where she served as vice president, corporate counsel, and general counsel for quality. She advised on compliance strategy, governance, and risk across manufacturing operations in the United States, Europe, Asia, and Latin America.
She brings more than 20 years of experience in compliance, enforcement, and regulatory affairs. During previous her tenure at CTP, Zeller helped direct nationwide tobacco compliance and enforcement planning and operations.
Her earlier FDA positions also included serving as the inaugural ombudsman for the agency’s Office of Regulatory Affairs (now the Office of Inspections and Investigations) and as associate chief counsel and trial attorney in the FDA’s Office of Chief Counsel.
The appointment comes as CTP continues to oversee enforcement against unauthorized tobacco products, including e-cigarettes and nicotine pouches, through inspections, warning letters, civil monetary penalties, and other regulatory actions.
Zeller’s selection followed multiple interview panels, ethics and security reviews, and the Office of Personnel Management’s Senior Executive Service process, according to the agency.
She holds a biology degree from Xavier University, a law degree, and a master’s degree in bioethics from the University of Virginia.
NI could not confirm if Jessica Zeller is of any relation to former CTP director Mitch Zeller, who led the FDA’s Center for Tobacco Products from March 2013 until his retirement in April 2022. Jessica served as the office’s inaugural deputy director from July 2011 through June 2013.
