By Timothy S. Donahue

Top Takeaways:

• Permanent post: HHS named Bret Koplow director of FDA’s Center for Tobacco Products after more than a year as acting director.
• FDA veteran: Koplow joined FDA in 2011 and has held senior legal, policy and regulatory positions across the agency.
• Critical stretch: He takes the permanent job as CTP changes product-review policies while facing major litigation over how it regulates tobacco and nicotine products.

Bret Koplow can finally drop “acting” from his title.

The U.S. Department of Health and Human Services has named Bret Koplow as the permanent director of the Food and Drug Administration’s Center for Tobacco Products (CTP), keeping the longtime FDA lawyer at the helm of the division responsible for regulating tobacco and nicotine products.

HHS announced the appointment on Sept. 8 as part of a group of senior FDA leadership selections. Michael Davis was named the permanent director of the Center for Drug Evaluation and Research; Karim Mikhail will lead the Center for Biologics Evaluation and Research; and Jared Seehafer was selected as FDA’s first deputy commissioner for technology and artificial intelligence.

Koplow has led CTP on an acting basis since 2025, following Brian King’s removal from the center amid broad personnel cuts at HHS. By May 2025, FDA records already listed Koplow as acting director.

He becomes the fourth permanent director of CTP since the center was established after the 2009 Tobacco Control Act was passed. Lawrence Deyton was its founding director, followed by Mitch Zeller and King.

Koplow joined the FDA in 2011 and spent much of his career in legal and policy roles. Before joining CTP, he served as senior counselor to the FDA commissioner beginning in 2020, focusing largely on tobacco regulatory, policy, and operational matters. His earlier positions included senior counsel in the FDA’s Office of the Chief Counsel and senior adviser for oversight in the Office of Legislation.

Before joining the FDA, Koplow practiced food and drug law in Washington. He is a graduate of the University of Chicago Law School and holds a doctorate in clinical psychology. Before attending law school, he worked as a clinical psychologist and directed child and adolescent psychiatry divisions at Case Western Reserve University School of Medicine and at University Hospitals of Cleveland.

HHS said Koplow will lead CTP with two priorities: expanding innovation and access to lower-risk alternatives for adult smokers while protecting youth and minors from tobacco and nicotine products.

The permanent appointment comes at one of the most consequential periods for CTP since the FDA began implementing premarket review requirements for deemed tobacco products.

Because FDA Center Directors are senior career or administrative leadership roles rather than Senate-confirmed positions, Koplow’s transition from acting director to permanent director is finalized by the department’s announcement and does not involve congressional approval.

Under Koplow, the center has publicly emphasized faster, more efficient reviews of tobacco products. In May, Koplow said CTP had taken action on premarket applications for nearly 27 million tobacco products over the previous five years and had reduced its application backlog by about 70% in 2025.

The FDA has also accelerated reviews of certain nicotine products and shifted its approach to products that may offer lower-risk alternatives for adult smokers. At the same time, the center continues enforcement actions against unauthorized products, particularly illicit e-cigarettes entering the United States. Koplow said during a 2025 seizure operation that regulators were seeing an increasing number of vaping shipments “packaged and mislabeled to avoid detection.”

The regulatory environment surrounding Koplow is also increasingly being shaped by federal court.

The Fifth and Ninth Circuits recently reached conflicting conclusions about the FDA’s approach to reviewing flavored e-cigarette applications, creating a significant legal dispute over whether the agency imposed a new comparative-efficacy requirement without notice and comment.

Altria also sued the FDA last week over delays in CTP’s premarket tobacco product application process, arguing that the agency has failed to meet the 180-day review timetable set by federal law.