Smoking kills half a million Americans every year — a devastating and decades-long toll that has become tiresome but still deserving of bold, science-driven solutions. For millions of smokers, kicking the habit once and for all is an impossibly difficult challenge that will end with disastrous health problems.

Instead of embracing bans and pushing entrenched misconceptions, the Trump administration has an opportunity to embrace innovation and common sense to extend the lives of American adult smokers.

Fortunately, the nominations of Martin Makary for Food and Drug Administration commissioner and Jay Bhattacharya for National Institutes of Health director suggest a shift toward those principles. Both are renowned for challenging the rigid healthcare orthodoxy rampant in federal tobacco policy, and they have the potential for transformative leadership in tackling massive mortality from smoking. Their appointments can potentially shape America’s public health prospects for years.

Tobacco harm reduction is a science-based approach that offers smokers vastly safer, smoke-free consumer nicotine products to replace their combustible cigarettes. Smoke-free products such as e-cigarettes and nicotine pouches have been shown to reduce smoking-related deaths. Public health authorities — including the United Kingdom National Health Service, the British Royal College of Physicians and the FDA — widely recognize that empowering smokers with accurate information about these safer options could drive significant reductions in smoking rates and consequential deaths.

Misleading narratives about nicotine persist, creating unnecessary confusion. Many Americans and, incredibly, most physicians still incorrectly believe that nicotine is the primary cause of harm from smoking. In fact, it’s burning cigarettes and inhaling smoke that causes all smoking-related illnesses. Unfortunately, the FDA didn’t correct nicotine misinformation or report the established vast difference in harm between smoke and smoke-free. On top of that, the agency’s complex and costly authorization process for vapor products stifled innovation and delayed or completely blocked smokers’ access to life-saving nicotine alternatives.

The FDA’s contradictory approach to product approvals has exacerbated these challenges — demanding exhaustive, prohibitively expensive research to approve safer nicotine products while doing little to dispel misinformation about their benefits. 

Due to its Pre-Market Tobacco Application process and bureaucratic inefficiencies, the FDA has authorized only 34 vaping products out of 26 million applications. This regulatory bottleneck has stymied innovation and left millions of smokers without viable options. 

One bright star in an otherwise dark regulatory sky was seen with the FDA authorization of several Zyn nicotine pouches.

The FDA’s failure to authorize products to meet consumer demand while simultaneously failing to enforce its own regulations has created a massive American illicit market, in which 99 percent of vape products are unauthorized. This fuels massive insecurity among adult smokers considering a switch away from combustion. 

Failures of federal policy have resulted in state and local government bans. Unfortunately, bans only move sales from a regulated legitimate market to an unregulated, illicit market, where safety and quality are nonexistent. Federal officials may not remember Prohibition, which produced thousands of deaths from tainted alcohol. However, surely they recall when e-cigarettes were wrongly implicated by the Centers for Disease Control and Prevention in a 2019-20 lung injury outbreak that stemmed from contaminated marijuana vaping products, resulting in 2,800 hospitalizations and 68 deaths.

Makary’s potential leadership at the FDA represents an opportunity to embrace innovation to ensure adult smokers can switch to vastly less harmful smoke-free nicotine products. By streamlining approval for safer products while maintaining rigorous safety standards, the FDA can encourage innovation and make these alternatives more accessible to adult smokers. 

Public education campaigns must also be reimagined to emphasize the continuum of risk associated with consumer nicotine products, empowering smokers with accurate, science-based information.

Similarly, Bhattacharya’s appointment to the NIH could reinvigorate research into alternative nicotine products and their role in harm reduction. A champion of evidence-based policymaking, he has a history of challenging public health dogmas. Under his leadership, the NIH could prioritize research into the long-term health effects of harm reduction strategies, equipping policymakers with the data needed to expand access to innovative cessation aids.

The administration has a rare chance to redefine the national conversation on smoking and nicotine. By prioritizing science over outdated narratives, expanding access to innovative smoke-free products like vapes and nicotine pouches, and streamlining the FDA’s burdensome authorization process, the administration could empower millions of smokers to transition to less harmful alternatives, and significantly reduce smoking-related deaths. 

Moreover, targeting education about safer alternatives to vulnerable populations, such as veterans and communities disproportionately affected by smoking, could help close health disparities.

The stakes are high — a half million premature deaths annually — but the solutions are within reach. With thoughtful leadership and evidence-based policymaking, we can chart a course for smokers and the nation’s public health.