2025 has proved to be a dynamic year in the tobacco and nicotine regulatory landscape, full of changes, court actions and legislative proposals.
After the Trump administration took office in January, there have been significant developments at the Food and Drug Administration (FDA) and the Center for Tobacco Products (CTP). There is new leadership at the Department of Health and Human Services as Secretary Robert F. Kennedy Jr. took office and Dr. Marty Makary became FDA commissioner. In late March, the administration made sweeping changes at CTP, removing Director Dr. Brian King and gutting many other departments. Since then, Bret Koplow has been temporarily filling the role of director of CTP. Koplow has worked in various roles for the FDA since 2011, including most recently as senior counselor to the commissioner.
With these developments, many see this as an opportunity for FDA/CTP to reset and streamline its operations. Rather than focus on banning certain tobacco products and with hundreds of thousands of nicotine product premarket tobacco product applications (PMTA) still pending before the agency, particularly in the vapor and nicotine pouch space, FDA has an opportunity to provide adult cigarette consumers with more authorized product choices that potentially present less risk.
Coupled with PMTA authorizations, there is also an opportunity for the agency to provide retailers with more transparency, specifically with respect to information on illicit products in the vapor and nicotine pouch categories and to increase enforcement efforts against these products.
To that end, the FDA issued PMTA marketing granted orders (MGO) for JUUL pods and device, which included JUUL pods Virginia Tobacco 3.0% and 5.0%, JUUL pods Menthol 3.0% and 5.0%, and JUUL device. In authorizing MGOs, the FDA has determined that these products “are appropriate for the protection of public health.”
Further, the FDA has launched a pilot program that aims to increase efficiency and streamline the review process for PMTAs for nicotine pouch products. The FDA said it would use tobacco harm reduction and the continuum of risk in reviewing applications since there is evidence that nicotine pouches can help some adults switch away from more harmful tobacco products.
On the enforcement front, in September, Secretary Kennedy and Attorney General Pam Bondi announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million — the largest-ever seizure of this kind. This was part of a joint federal operation where shipments were uncovered of various illegal e-cigarette products, almost all of which originated in China. The FDA is also focused on education, as recently they sent information to increase voluntary compliance from all U.S. tobacco and nicotine retailers.
State Level Changes
Within state legislatures, most states have wrapped up their sessions. Some states turned to increased tobacco and nicotine taxes for varying reasons, including to fill budget deficits, to fund programs and to capture new revenue sources from nicotine pouches.
In total, 10 states have hiked tobacco or nicotine excise taxes. To follow are some of these increases and why the states acted:
• Indiana: In April, with only a few weeks remaining in their legislative session, legislators realized they were facing a $2.4 billion deficit. To help address this, lawmakers turned to tobacco and nicotine and applied a significant “across the board” approach, increasing the cigarette tax from $1 to $3 per pack; other tobacco products from 24% to 30% of the wholesale price; moist snuff from 40 cents to 50 cents per ounce; nicotine pouches from 40 cents to 50 cents per ounce; closed system vapor cartridges from 15% to 30% of the wholesale price and vapor consumable material (open systems) from 15% to 30% at retail.
• Oregon: Looking to provide funding for a wildlife prevention program, legislators enacted a new tax on oral nicotine products — for packages with 20 consumable units or less, an excise tax of 65 cents per can and for packages with more than 20 consumable units, a tax of 3.25 cents per consumable unit.
• Tennessee: Coming into this year, Tennessee was one of 18 states that did not have an excise tax on vapor products. As of July 1, the state now taxes these products at 10% of the wholesale price.
A continuing emerging issue in the states is the creation of state vapor product directories. After last year’s state sessions, 10 states are in the process of creating state vapor directories, and 20 additional states considered legislation in 2025, with Arkansas, Mississippi and Tennessee passing directories. The introduction of these bills has been in response to the uncertainty around the FDA PMTA process and the proliferation of illicit flavored disposable e-cigarettes on the market.
The FDA has not completed processing applications for thousands of e-cigarettes and has only approved the marketing of 39 vapor products, making it unclear to retailers and the public of the regulatory status of a large number of products, such as those for which a PMTA was never filed, those for which a PMTA was timely filed and the application is awaiting an order, and those for which a PMTA was denied but the application remains pending for legal reasons. These bills create a state-based directory that requires e-cigarette manufacturers to submit information to state tobacco regulators demonstrating that any e-cigarette being sold in the state is in compliance with FDA regulations and guidance.
Also, Massachusetts and Nevada considered bills that would create a “nicotine-free generation.” This issue first appeared on the local level where several Massachusetts towns have banned the sale of tobacco and nicotine products to anyone born after a certain date.
The National Association of Tobacco Outlets (NATO) has been leading engagement efforts to inform stakeholders that these misinformed policies are not about youth; they instead target adults 21 and older who should have the right to choose which legal products they purchase and use.
David Spross is the executive director of the National Association of Tobacco Outlets, a national retail trade association that represents more than 66,000 stores throughout the country.
