EMA Journal • Fall 2025 • At NATO

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 (HHS) 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 the 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 their operations. Rather than focus on banning certain tobacco products, and with hundreds of thousands of nicotine product Premarket Tobacco Product Applications (PMTAs) still pending before the agency, particularly in the vapor and nicotine pouch space, the 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 (MGOs) for JUUL pods and the JUUL device, which included JUUL pods Virginia Tobacco 3 percent and 5 percent, JUUL pods Menthol 3 percent and 5 percent, and the JUUL device. In authorizing MGOs, the FDA has determined that these products “are appropriate for the protection of public health.” Additionally, the U.S. Senate Appropriations Committee approved an FDA appropriations package, which includes increased enforcement funding ($200 million allocated) to combat illicit flavored disposable e-cigarettes and nicotine pouch products illegally imported into the U.S. The package also includes language expressing the committee’s concern that the FDA has not completed its review of PMTA applications and urges the FDA to promptly complete this process.

On the federal regulatory front, shortly after President Donald Trump took office, the FDA withdrew two proposed rules that would have banned the sale of menthol cigarettes and flavored cigars. Both rules were pursued by the previous administration.

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 percent to 30 percent of the wholesale price; moist snuff from $0.40 to $0.50 per ounce; nicotine pouches from $0.40 to $0.50 per ounce; closed-system vapor cartridges from 15 percent to 30 percent of the wholesale price; and vapor consumable material (open systems) from 15 percent to 30 percent at retail.

• Oregon: Looking to provide funding for a wildfire 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 percent 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 of 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 as several Massachusetts towns banned the sale of tobacco and nicotine products to anyone born after a certain date. 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.

by David Spross, Executive Director, National Association of Tobacco Outlets (NATO). NATO is a national retail trade association that represents more than 66,000 stores throughout the country.