As CTP director, Koplow will focus on encouraging innovation and access to potentially less harmful alternatives while protecting youth from tobacco and nicotine products. Photo credit: US FDA
Bret Koplow, Ph.D., J.D., will serve as the director of the US Food and Drug Administration’s Center for Tobacco Products (CTP), the Department of Health and Human Services (HHS) announced.
Koplow had served as CTP’s acting director before the appointment. HHS included his selection among four senior FDA leadership appointments, alongside Michael Davis as director of the Center for Drug Evaluation and Research, Karim Mikhail as director of the Center for Biologics Evaluation and Research, and Jared Seehafer as FDA’s first deputy commissioner for technology and artificial intelligence.
Koplow joined FDA in 2011 and has held senior legal, policy, and leadership positions across the agency. Before taking over CTP, he served as senior counselor to the FDA commissioner, focusing primarily on regulatory, policy, and operational matters involving tobacco products. He previously worked in FDA’s Office of the Chief Counsel and Office of Legislation.
Before joining FDA, Koplow practiced food and drug law as a partner at international law firms in Washington, DC. He graduated with honors from the University of Chicago Law School and holds a Ph.D. in clinical psychology. Before attending law school, he worked as a clinical psychologist and directed the Divisions of Child and Adolescent Psychiatry at Case Western Reserve University School of Medicine and University Hospitals of Cleveland.
HHS said Koplow’s priorities as CTP director will include promoting innovation and access to less harmful alternatives for adults who smoke, while taking action to protect youth and minors from tobacco and nicotine products.
The permanent appointment follows a period of activity at CTP under Koplow’s acting leadership. In May, the center reported that it had reduced its premarket tobacco product application backlog by about 70% during 2025 and eliminated its queue for initial acceptance review. Koplow also highlighted a pilot program for nicotine pouch applications that resulted in authorizations for six products within three months.
CTP has also continued enforcement activity against unauthorized tobacco and nicotine products. In June, FDA issued warning letters to eight retailers over unauthorized nicotine pouches and dissolvable tobacco products that the agency said resembled candy, breath strips, and cough drops. At the time, Koplow said, “no tobacco product should look like candy.”
The center operates under the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009 and which gives the FDA authority over the manufacturing, distribution and marketing of tobacco products. CTP develops policy and regulations, conducts research and reviews new tobacco product applications and claims before products can legally enter the US market.
HHS secretary Robert F. Kennedy Jr. said the appointments would help build an FDA that “moves faster, demands excellence, and delivers results for the American people.” FDA Acting commissioner Kyle Diamantas said the selections “signal the direction we are heading” and would support efforts to build the agency’s workforce and infrastructure and accelerate innovation across its centers.