New Leadership at FDA Signals Renewed Focus on Tobacco Enforcement

New Leadership at FDA Signals Renewed Focus on Tobacco Enforcement
The U.S. Food and Drug Administration (FDA) has announced two high-profile leadership changes that could significantly impact the future of tobacco regulation and enforcement in the United States. Elizabeth Miller and Bret Koplow—two seasoned FDA veterans—have been tapped to lead the agency’s Office of Inspections and Investigations and Center for Tobacco Products (CTP), respectively.

Who Are the New Leaders?

Elizabeth Miller, a pharmacist by training, will now serve as Acting Associate Commissioner for the Office of Inspections and Investigations. With a background in overseeing FDA inspections of both medical and tobacco-related products, Miller brings deep institutional knowledge to a role that is central to ensuring regulatory compliance across industries.

Bret Koplow, who holds both a Ph.D. and J.D., steps in as Acting Director of the CTP following the exit of Brian King, who held the position since July 2022. Koplow’s dual expertise in science and law positions him well to navigate the agency’s evolving regulatory landscape.

Why This Matters

These appointments come at a pivotal time. The FDA is facing increasing scrutiny from lawmakers, public health groups, and industry stakeholders over its handling of the U.S. vaping market—particularly concerning unauthorized and illicit disposable products. Pressure is mounting for the agency to enforce its policies more consistently and to modernize outdated inspection and compliance systems.

In tandem with these leadership shifts, the FDA is also conducting a comprehensive review of its foreign inspection processes. This is part of a broader effort to ensure product safety and regulatory integrity amid rising concerns over supply chains and imported goods.

A New Era for the FDA?

FDA Commissioner Marty Makary has voiced his support for the changes, calling them a “strategic investment in leadership at a time when our agency is navigating some of the most complex public health challenges in recent memory.” He emphasized the need for experienced, decisive leaders to reinforce the agency’s regulatory and enforcement missions.

While the long-term impact of these appointments remains to be seen, one thing is clear: the FDA is signaling a renewed commitment to strengthening oversight, improving compliance, and restoring confidence in its regulatory authority over tobacco and nicotine products.

As these changes take effect, all eyes will be on the agency’s next moves—particularly regarding enforcement against illicit vape products and the future of harm-reduction strategies in tobacco control.