Expanding the THR Caucus Could Be Key to Modernizing U.S. Tobacco Policy

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Key Points:

• Caucus Growth: Reps. Byron Donalds (R-FL) and Aaron Bean (R-FL) join the bipartisan U.S. House Tobacco Harm Reduction Caucus, chaired by Reps. Guy Reschenthaler (R-PA) and Don Davis (D-NC).

• Mission: Caucus promotes adoption of harm reduction products and innovation to reduce smoking-related disease.

• Regulatory Barrier: FDA’s outdated PMTA process, tied to a 2007 predicate date, blocks most new products while approving changes to more dangerous cigarettes.

• Limited Approvals: As of Aug. 2025, only 81 products have FDA marketing orders – just 39 are e-cigarettes – serving over 20 million U.S. adult vapers.

• Florida Impact: From 2016–2023, adult smoking fell 32.3 percent and vaping rose 61.7 percent in Florida; mirrors national declines in smoking and increases in vaping.

• Global Examples: Countries like Canada, New Zealand, UK, Japan, Hungary, and Sweden show harm reduction can sharply cut smoking rates.

• Policy Need: Congress could change the predicate date and target enforcement at bad actors to expand adult access to safer alternatives.

• Public Health Gap: Youth tobacco use is at record lows, yet 30+ million American adults still smoke – many unaware of less harmful options.

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It was announced this week that two additional members have joined the U.S. House Tobacco Harm Reduction Caucus. Chaired by Representatives Guy Reschenthaler (R-PA) and Don Davis (D-NC), the caucus was first referenced in House Resolution 979 of the 118th Congress, which urged public health authorities to “embrace harm reduction as part of the comprehensive United States approach to tobacco control.” The newest members are Byron Donalds (R-FL) and Aaron Bean (R-FL).

The House Tobacco Harm Reduction Caucus is a bipartisan effort focused on the adoption of tobacco harm reduction products and innovation to reduce the toll of combustible cigarette use. Originally founded in 2023 during the 118th Congress and later “reconstituted” that same year, the caucus serves as a forum to address all facets of the tobacco public health debate – from preventing underage use, to improving public understanding of harm reduction products.

The addition of new members is a welcome and overdue development. In 2009, Congress gave the U.S. Food and Drug Administration authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (TCA). The TCA granted FDA broad regulatory powers over manufacturing, distribution, and marketing, and created the Center for Tobacco Products. The law allows FDA to set product standards for nicotine levels, ingredients, and design – but explicitly bars the agency from eliminating nicotine entirely.

A major flaw of the TCA is its treatment of “new tobacco products,” defined by the arbitrary standard of whether they were substantially equivalent to a product on the market before February 15, 2007. Products similar to those available before that date can apply through the Substantial Equivalence pathway; all others must endure the costly and burdensome Premarket Tobacco Product Application (PMTA) process. This process is outdated, restrictive, and ignores the potential of tobacco harm reduction, stifling innovation while FDA continues to approve changes to far more dangerous combustible cigarettes.

As of August 2025, only 81 products have received FDA marketing granted orders via PMTA. In 2024, FDA issued marketing orders for 262 products – but just 11 were PMTA approvals. The rest were largely for products deemed substantially equivalent to those predating 2007. Of the 81 products FDA has found “appropriate for the protection of public health,” only 39 are e-cigarettes – a paltry number for the more than 20 million American adults who vaped in 2023.

The new caucus members represent millions of adults who smoke and vape. In Florida, home to both Donalds and Bean, about 1.9 million adults smoked cigarettes and 1.4 million used e-cigarettes in 2023. Federal data show that since e-cigarettes were introduced, smoking rates in Florida have dropped sharply – down 32.3 percent from 15.5 percent in 2016 to 10.5 percent in 2023 – while adult vaping rose 61.7 percent from 4.7 percent to 7.6 percent.

This mirrors national trends. Between 2016 and 2023, U.S. adult smoking rates fell 30.7 percent (17.5 percent to 12.1 percent) while vaping rates climbed 68.6 percent (4.6 percent to 7.79 percent).

Globally, countries such as Canada, New Zealand, and the UK are actively promoting e-cigarettes to help adults quit smoking, while heated tobacco products have driven steep smoking declines in Hungary, Japan, and South Korea. Sweden’s decades-long use of snus has yielded some of Europe’s highest tobacco use rates but lowest smoking-related disease rates.

In the United States, however, federal regulations continue to block many safer alternatives from reaching market. There are practical solutions: Congress could pass legislation to change the predicate date, sparing many products from the PMTA gauntlet, or direct FDA to use enforcement discretion against noncompliant bad actors rather than legitimate businesses serving adult consumers.

Youth tobacco use is at record lows – with e-cigarette use at its lowest point in more than a decade – yet over 30 million American adults still smoke. Many remain unaware of significantly less harmful alternatives that can help them quit.

It will take Congressional leadership – particularly from the House Tobacco Harm Reduction Caucus – to reform FDA’s arbitrary tobacco application processes and accelerate the transformation of the U.S. tobacco landscape.

Nothing in this analysis is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.