Introducing Policy & Progress in Tobacco Harm Reduction & Thoughts on Where THR Can Go with President Trump

Welcome to Policy & Progress in Tobacco Harm Reduction, a space dedicated to sharing developments in the global tobacco harm reduction (THR) landscape. This Substack is born from a desire to see an ever more robust, science-driven public dialogue around our country’s collective efforts to reduce and eventually end the premature death and disease associated with cigarette smoking.

On these pages, I will share some thoughts on developments in industry, regulation and policymaking in the global effort to eliminate the death and disease caused by smoking. These updates will be leavened by my personal perspective, shaped by working on regulatory and government policy, product innovation, and harm reduction, over the last 25 years.

From the pre-FDA oversight era, through the implementation of the Tobacco Control Act, to the push for innovative products that may help adults who smoke transition away from cigarettes to potentially less harmful alternatives, I have had the privilege of observing and participating in the twists and turns of an issue that is of critical importance.

With the 2024 election in the rearview mirror - and the US policy landscape entering a time of transition – there’s no better moment to contribute to the conversation.

Disclosure: I'm employed by Juul Labs, but the opinions expressed here are my own. While I cannot claim to be free of bias, my effort here will be to offer a fact-based, balanced view.

Trump Transition Offers a Pathway for Regulatory Correction

As President Trump and his team prepare to lead the nation, they face a historic opportunity to improve public health by accelerating the decline of smoking rates in the US.

Since 2009, adult cigarette use has been cut by nearly 50% - cause for celebration. Yet nearly 30 million Americans still smoke, and smoking remains the leading cause of preventable death in the country.

Contrast that with the experience of Sweden. There, government has for many years encouraged the widespread availability of potentially less harmful alternatives to cigarettes, like snus and e-cigarettes. Thanks in large part to those efforts, this past week Sweden was able to announce that its smoking rate is now below 5% - which meets the EU standard for being a “smoke free” nation. While I have seen some quibble whether this smoking rate truly qualifies as “smoke free”, under any measure, this strikes me as a remarkable achievement, and one that was delivered ahead of schedule.

President Trump is well known for liking big, audacious goals. Making America smoke free can and should be one of them.

That will require an embrace of the compelling evidence that shows lawfully marketed ENDS (electronic nicotine delivery system) products offer a compelling alternative to Americans who smoke and either can’t or won’t otherwise quit. Building on progress made during his first term, like Tobacco 21 and then-FDA Commissioner Scott Gottleib’s plan to reduce tobacco-related harm, Trump can kick start a more efficient FDA, allocate sufficient resources, and catapult the agency to a stronger position of science-backed regulation and enforcement against the dangerous illicit marketplace.

This is a needed pivot. Under the outgoing administration, only 34 ENDS products have been authorized. At the same time, a massive illicit market of more than 60,000+ disposable vapor products, including countless youth-appealing flavors, is prevalent throughout the country. These products threaten public health and the progress we’ve made in reducing underage use of tobacco and vapes (underage use of Juul products has declined 98% since 2019, while total underage use of ENDS has fallen to 5.9%).

Authorizing more products that are backed by solid science and evidence will be key to eliminating the illegal market and will support an “all of the above” strategy of offering adults who smoke a wide array of paths away from cigarettes, including alternative products, prescription medications, traditional nicotine replacement products, therapy and more.

In my next piece, I’ll talk about what the government and industry need to achieve these goals, including FDA resources to enhance its science-based application review process and to step-up market enforcement; what a streamlined process can look like for product development and review based on clear standards and guidance; and how President Trump can accelerate CTP’s Strategic Plan and help nearly 30 million American switch away from smoking cigarettes for good.