FDA

The U.S. Food and Drug Administration (FDA) has named Jessica Zeller director of the Center for Tobacco Products' (CTP) Office of Compliance and Enforcement (OCE), effective November 1, 2026. Zeller, the office's inaugural deputy director, returns from medical device manufacturer Edwards Lifesciences with more than 20 years of regulatory and legal experience. The appointment follows CTP leadership changes and adjustments to tobacco regulation. Bret Koplow became permanent CTP director in September; the FDA revised enforcement priorities for unauthorized e-cigarettes and nicotine pouches in May and announced faster PMTA review procedures. On September 28, the agency said it would evaluate changes to the existing PMTA regulatory framework, including potential rulemaking to replace it.

FDA’s Center for Tobacco Products is reshaping how it approaches tobacco product review. Based on 2Firsts’ on-site reporting in New York and Washington, this report traces CTP’s emerging direction: stronger links between PMTA and tobacco harm reduction, more category-specific review, greater emphasis on decision-relevant science, more predictable timelines and expanded use of sPMTA for product modifications. CTP also acknowledged major constraints, including just nine PMTA review teams, persistent backlogs and limits on hiring capacity.

The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.

FDA’s launch of a web-based PMTA system signals faster reviews and, 2Firsts experts say, a possible inflection point for the U.S. e-cigarette market’s shift out of the grey zone.

The Committee on Energy and Commerce announced a hearing on FDA projects on September 10, 2024, in Washington, D.C.

Latest data from FDA and CDC shows a 500,000 decrease in US youth e-cigarette use in 2024 compared to 2023.

Illinois Attorney General Kwame Raoul joins a 19-state coalition supporting FDA in effort to block flavored e-cigarette sales across states.