Key Points
Jessica Zeller will become director of the FDA's Office of Compliance and Enforcement within CTP on November 1, 2026.
Zeller has more than 20 years of experience and previously served as OCE's inaugural deputy director and as the FDA Office of Regulatory Affairs' inaugural ombudsman.
She joins from Edwards Lifesciences, where she held senior legal and quality compliance roles involving manufacturing operations in the United States, Europe, Asia and Latin America.
Bret Koplow was formally appointed CTP director in September. FDA's October 13 organizational chart listed Jill Atencio as acting director of OCE.
On May 8, the FDA issued enforcement-priority guidance outlining conditions under which it generally would not prioritize enforcement against certain unauthorized e-cigarette and nicotine pouch products with qualifying pending applications.
On May 7, CTP reported a roughly 70% reduction in its PMTA application backlog during 2025. On September 28, the FDA announced plans to evaluate regulatory changes, potentially replacing the existing PMTA framework through new rulemaking.
2Firsts
October 20, 2026
The U.S. Food and Drug Administration (FDA) has named Jessica Zeller as the next director of the Office of Compliance and Enforcement (OCE) within its Center for Tobacco Products (CTP), effective November 1, 2026, according to an agency announcement. Zeller previously served as the office's inaugural deputy director and is returning to the FDA from medical device manufacturer Edwards Lifesciences.
Her appointment follows several leadership and regulatory developments at CTP. Bret Koplow became the center's permanent director in September, while the FDA revised enforcement priorities for unauthorized e-cigarettes and nicotine pouches in May and announced measures to accelerate premarket tobacco product application (PMTA) reviews. On September 28, the agency said it would evaluate changes to the current PMTA regulatory framework, including new rulemaking that could replace the existing 2021 regulations.
Former Inaugural Deputy Director Returns With More Than 20 Years of Regulatory Experience
According to the FDA, Zeller has more than 20 years of experience leading compliance, enforcement, legal and regulatory affairs programs.
During her previous tenure at the agency, she served as the inaugural deputy director of CTP's Office of Compliance and Enforcement, helping direct nationwide tobacco compliance and enforcement planning and execution.
Zeller also served as the inaugural ombudsman for the FDA's Office of Regulatory Affairs, now known as the Office of Inspections and Investigations. Her work included addressing procedural issues involving FDA field offices, inspections and imports.
She previously held positions as associate chief counsel and trial attorney in the FDA's Office of Chief Counsel, advising agency leadership on compliance and enforcement authorities.
According to a biography published by the Food and Drug Law Institute (FDLI) in 2022, Zeller also served as the lead FDA lawyer for matters involving Procter & Gamble.
Zeller Returns From Edwards Lifesciences, Bringing Global Manufacturing Compliance Experience
Before her return to the FDA, Zeller served as vice president, corporate counsel, and general counsel for quality at U.S. medical device manufacturer Edwards Lifesciences.
The FDA said she advised on compliance strategy, governance and risk across manufacturing sites in the United States, Europe, Asia and Latin America.
FDLI materials published in 2022 identified Zeller as vice president, quality, regulatory and public affairs counsel at Edwards Lifesciences. Her responsibilities included global medical device regulatory compliance and quality systems matters, and she participated in professional discussions about FDA engagement and regulatory procedures.
Zeller also co-edited the 2022 book How FDA Really Works: Insights from the Experts with Wayne L. Pines. Published through FDLI, the 24-chapter volume covers FDA product applications, regulatory compliance, policy matters and engagement with the agency.
She holds a bachelor's degree in biology from Xavier University, a Juris Doctor from the University of Virginia School of Law and a master's degree in bioethics from the University of Virginia.
The FDA said her appointment followed an extensive search, multiple interview panels, ethics and security reviews, and the Office of Personnel Management's Senior Executive Service process.
Zeller to Lead Tobacco Compliance and Enforcement Following CTP Leadership Changes
Zeller's appointment follows recent leadership changes at the FDA's Center for Tobacco Products.
In September 2026, Bret Koplow was formally appointed CTP director after serving in an acting capacity. Koplow previously worked on tobacco-related regulatory, legal and operational matters in the FDA Commissioner's Office before becoming acting CTP director in 2025.
The FDA's October 13 organizational chart listed Jill Atencio as acting director of the Office of Compliance and Enforcement. Zeller is scheduled to assume leadership of the office on November 1.
OCE oversees tobacco product compliance and enforcement involving manufacturers and retailers, including investigations, warning letters, civil monetary penalties, and legal actions seeking product seizures or injunctions.
FDA Revises Enforcement Priorities for Unauthorized E-Cigarettes and Nicotine Pouches
On May 8, 2026, the FDA issued guidance titled Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization, outlining enforcement policies for certain unauthorized electronic nicotine delivery systems (ENDS) and nicotine pouch products.
Under the guidance, the FDA generally does not intend to prioritize enforcement of premarket authorization requirements against products with qualifying applications that have been accepted and filed, or qualifying pending supplemental PMTAs, subject to specified conditions.
For non-tobacco-flavored ENDS products, the FDA also requires the relevant applications to contain data sufficient to evaluate whether the products meet the statutory public health standard.
The guidance identifies product features that may trigger enforcement priority, including cartoon-like imagery, devices disguised as other consumer electronics, products resembling children's toys, and significant health or safety concerns such as high nicotine content, inadequate child-resistant packaging or potential fire hazards.
The FDA also announced plans for a public list identifying manufacturers and products that would not be prioritized for enforcement under the policy.
The agency continues to target products involving failures to submit required premarket applications, counterfeiting, misdeclaration and other serious violations. It said it would work with the U.S. Department of Justice (DOJ), Customs and Border Protection (CBP) and other federal agencies to intercept, seize and destroy unlawfully imported tobacco products.
FDA Reports 70% Reduction in PMTA Backlog and Moves to Accelerate Reviews
On May 7, then-acting CTP Director Bret Koplow outlined new measures to improve the efficiency of PMTA reviews.
Koplow said CTP had taken regulatory action over the preceding five years on applications covering nearly 27 million tobacco products and reduced its application backlog by approximately 70% in 2025.
The FDA said it had eliminated the queue for PMTA acceptance review, allowing newly submitted applications to enter the first stage of review almost immediately.
CTP was also improving filing review and scientific assessment procedures. Where some products in an application are ready for marketing granted orders while others require additional information, the FDA is exploring ways to review and decide on them separately.
The center is also developing a process to accelerate reviews of certain supplemental PMTAs involving modifications to previously authorized products, including changes reflecting improvements in electronics technology.
For nicotine pouches, the FDA launched a review-efficiency pilot program in September 2025 and granted marketing authorization to six new products in December, three months after scientific review began. CTP said it intended to apply lessons from the pilot more broadly to nicotine pouch PMTA reviews.
FDA Considers Replacing Existing PMTA Framework Through New Rulemaking
On September 28, 2026, the FDA announced plans to evaluate changes to the PMTA regulatory framework, including potential new rulemaking to replace the current regulations.
The agency cited its experience implementing the 2021 PMTA rule, the expansion of illicit and unregulated tobacco markets, the pace of new product introductions and recent judicial developments.
The FDA also referred to a federal lawsuit pending in the U.S. District Court for the Northern District of Texas challenging the current PMTA regulatory framework.
According to the agency, a revised framework should better reflect current market conditions and provide greater regulatory clarity and predictability while maintaining public health protections.
The FDA said it would continue processing PMTA submissions, conducting premarket reviews and issuing marketing decisions under existing statutory requirements while potential regulatory changes are considered.
Zeller is scheduled to take charge of CTP's Office of Compliance and Enforcement on November 1, overseeing the center's tobacco product compliance and enforcement activities.
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Cover Image Source: Jessica L. Zeller — LinkedIn Profile
