Key Points
- HHS formally appointed Bret Koplow as director of the FDA’s Center for Tobacco Products after his acting tenure.
- Koplow has worked at the FDA since 2011, with a long record in tobacco regulation, law and policy.
- During his acting tenure, CTP said it reduced the PMTA backlog by about 70% in 2025 and accelerated review processes.
- HHS said CTP will prioritize innovation and access to less harmful alternatives for adult smokers alongside youth protection.
2Firsts
September 9, 2026
According to an announcement by the U.S. Department of Health and Human Services on September 8, 2026, Bret Koplow has been formally appointed director of the U.S. Food and Drug Administration’s Center for Tobacco Products.
Koplow had already been serving as acting director. The appointment ends the center’s acting-leadership period and places the agency’s tobacco and nicotine regulatory arm under a permanent director.
Longstanding FDA Tobacco Policy Background
Koplow has worked at the FDA since 2011.
Before joining CTP leadership, he served from 2020 as a senior adviser to the FDA commissioner, focusing heavily on tobacco regulation, policy and operations.
Earlier roles included positions in the FDA Office of Chief Counsel and the Office of Legislation.
Koplow has both legal and clinical psychology training, giving him a background centered on regulatory law, policy implementation and agency operations rather than a purely scientific or public-health track.
Acting Tenure Focused on Faster PMTA Reviews
During his time as acting CTP director, Koplow made product-review efficiency a visible priority.
In a May 2026 statement, he said CTP had reduced the PMTA backlog by roughly 70% during 2025 and had eliminated queues at the acceptance stage.
The center also said it was working to improve filing and scientific-review efficiency and develop faster review pathways for certain supplemental PMTAs.
Nicotine pouches were another major focus.
CTP launched a nicotine pouch PMTA pilot and said the first decisions were completed within three months of scientific review beginning. The center said lessons from that pilot would be applied more broadly to nicotine pouch applications.
2Firsts previously reported that Koplow’s May statement placed increased emphasis on innovation and review efficiency, signaling a stronger focus on accelerating regulatory decision-making for tobacco and nicotine products.
HHS Highlights Innovation and Lower-Risk Alternatives
HHS also used the appointment announcement to define CTP’s priorities under Koplow’s permanent leadership.
The department said Koplow will lead efforts to advance innovation and increase access to less harmful alternatives for adult smokers while taking decisive action to protect American youth from tobacco and nicotine harms.
The wording places adult access to alternative products alongside youth protection as part of CTP’s formal priorities.
For vaping, nicotine pouch and heated tobacco companies, the statement indicates that product innovation and regulatory market access will remain central parts of the agency’s agenda.
Recent Authorizations Reflect Review Direction
During Koplow’s acting tenure, the FDA continued issuing decisions across several newer nicotine categories.
The agency advanced nicotine pouch reviews and authorized additional ZYN products and other pouches.
On August 28, the FDA also authorized the JUUL2 device and two 1.6% pods for marketing in the United States.
Those decisions are consistent with the center’s stated emphasis on improving review efficiency.
At the same time, the FDA has continued enforcement against unauthorized products, products with strong youth appeal and companies that violate marketing or sales requirements.
Koplow’s formal appointment therefore does not signal deregulation. It is more likely to continue the dual approach already visible under his acting leadership: faster review of compliant products combined with continued enforcement against unauthorized and youth-focused products.
CTP Enters a Permanent Leadership Phase
CTP oversees U.S. market authorization, product standards, marketing rules and enforcement for tobacco and nicotine products, making it one of the world’s most influential tobacco regulators.
Koplow’s move from acting to permanent director gives the center greater leadership continuity as it manages a large and evolving regulatory workload.
For industry, that stability also matters commercially.
PMTA, MRTP and other tobacco product regulatory pathways are lengthy, and companies depend heavily on predictable review standards, communication and enforcement timelines.
Under Koplow’s permanent leadership, the pace of review, treatment of innovative products and balance between adult access and youth protection will remain key regulatory signals for the U.S. vaping, nicotine pouch and heated tobacco markets.
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Cover Image:FDA
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