In Uncertain Times, Tobacco Harm Reduction Has a Unique Opportunity to Lead

The inevitable changes that come with a new administration are raising questions about the PMTA and the future of THR in America. But the responsibility to self-regulate, prioritize youth protection, and uphold scientific standards exist independently of the regulatory pathway and it is precisely these voluntary commitments to rigor and transparency that will separate credible, lasting companies from those that fade from the public memory. While some may view uncertainty as a challenge, it is a challenge that our ARAC team has gladly accepted for 3 years, thriving in the face of adversity by keeping the focus always on science, responsibility, and vision. In fact, many in the industry view this time as a prime opportunity to lead. 

A Changing Landscape 

Recently, the Trump administration initiated a significant reduction in force (RIF) at the FDA’s Center for Tobacco Products (CTP) and the CDC’s Office on Smoking and Health, impacting the agencies’ staffing and operational capacity. Since the initial RIF order on April 1st, the federal government has started to call back employees, which begs the question of how much the center, or the processes it oversees will really change under the new administration. FDA has, since 2008, been central to tobacco control and oversight in the U.S., and the apparent downsizing has sparked concern about what comes next for federal tobacco control, the industry, and the future of THR in America.  How will the RIF influence the agencies’ ability to meet the legislative mandate of reviewing PMTA applications within 180 days, especially given that even prior to the reductions, this timeline appeared difficult to achieve? Will the RIF be accompanied by new standards or streamlined processes that could expedite application reviews and clear the growing backlog?  

In any environment defined by uncertainty, leadership will not come from waiting for answers, but from stepping forward with clarity, responsibility, and vision. For harm reduction brands and advocates this is our moment to step forward, not back. 

Consumers Are Looking for Safer Choices 

We’re seeing a clear cultural shift toward health-conscious living. As Dr. Amit Mahajan of the American Lung Association noted in a recent USA TODAY interview, “People are looking for choices that align with their lifestyle and health goals. Safer nicotine products, when properly regulated, can offer that.” Leading public health reviews have found that reduced- risk nicotine products, including e-cigarettes (or, colloquially, vapes) are significantly safer than smoking (National Academies of Sciences, Engineering, and Medicine [NASEM], 2018), and recent research shows that e-cigarettes are more effective for smoking cessation than traditional NRTs (Cochrane Tobacco Addiction Group, 2024). The long-term consequences of RRP use continue to be debated, but smokers who fully switch to non-combustible alternatives experience measurable improvements in lung and cardiovascular function providing short-term evidence (at least) of health risk reduction (Balfour et al., 2021). 

With modern alternatives now outpacing NRTs in popularity, and with the FDA’s recent authorization of Zyn nicotine pouches (Associated Press, 2024), credible, science-backed brands have a strong foundation to support consumers seeking safer choices. At the same time, the shifting regulatory landscape presents both challenges and opportunities. With a degree of uncertainty over how regulatory resources will be deployed in the context of tobacco and nicotine product regulation, navigating product development and approval has become increasingly complex. In this evolving environment, maintaining alignment with FDA expectations, scientific standards, and public health priorities will be critical. Companies that stay grounded in these principles will be best positioned to move forward with confidence and most likely to see future success.  

Regulation Still Matters — And We Must Champion It 

While some regard recent developments as evidence that the new administration may relax regulatory standards, this is likely incorrect for several reasons. First, the CTP – the bureau responsible for reviewing PMTA applications - was created by statute. The foundational legislation, the Tobacco Control Act, cannot be repealed unless congress passes a new law; issues a resolution against the TCA under the Congressional Review Act, which then needs to be signed by the president; or otherwise the supreme court must rule the legislation to be unconstitutional. The recent SCOTUS ruling makes it clear that FDA's historic approach has judicial support, removing what would have been the quickest route to an indirect PMTA reform. To revise the TCA or PMTA guidance, it would take years to engage in legislative actions and/or significant public comment and justification for such change. Certainly,  the RIF orders have raised questions about the agency’s capacity to accelerate the review period for PMTA applications. Delays on this front have, understandably, caused some consternation among applicants. Note, however, that the structure and employees of CTP remain essentially unchanged. The offices that were more severely impacted include those dealing with regulation, suggesting (again) that structural reform will not be forthcoming. Further evidence that the FDA would not make radical changes to the PMTA process came last week when Commissioner Dr. Makary stated that he refused the proposal of FDA’s restructuring and has no plans to do so in the future. We know that the new administration has always been focused on increasing efficiencies and effectiveness of the federal government, which leads us to believe that the 180-day standard for decision-making may be enforced in the future. 

The lack of more significant structural changes to the FDA, CTP, or PMTA might frustrate those who view the approval process as being too burdensome; but effective harm reduction depends on regulation—not its absence. Clear, balanced regulatory frameworks give consumers tools to differentiate between higher- and lower-risk products, such as through differential taxation based on relative harm. For other examples, consider that many pharmaceuticals are sold over-the-counter, but those with known dangerous side-effects are more tightly controlled and require a prescription from a physician to prevent misuse; and Alcohol and (in regulated state markets) Cannabis regulators often impose higher taxes on more potent products to inform consumer behavior so as to reduce consumption-related harms. Regulation plays a critical role in making already-safer products safer still. When regulators strike the right balance, they create incentives for consumers to switch to lower-risk alternatives, helping to advance public health.  

The task for the new administration should be to facilitate and expedite submissions within the existing framework. If barriers to entry are set too high, consumers and suppliers may be pushed toward the unregulated market. This is exactly what we have witnessed with ENDS in the US.; here the overwhelming majority of products are not authorized. Illegal markets do not provide opportunities to guarantee safety standards or quality controls, and age restrictions are absent; there being little incentive to restrict access to minors among those already in violation of the law. For these reasons, withstanding the evidence that even unauthorized products help move consumers away from harmful cigarettes, greater opportunities for meaningful public health progress are lost if the market is dominated by illicit products. 

As former FDA tobacco director Mitch Zeller noted in an April 2025 interview with USA TODAY, the current void in federal strategy is concerning. But that void can be filled—by companies and advocates who are committed to responsible innovation. This new environment offers a chance to demonstrate responsible action through meaningful engagement with policy, compliance, and public trust. That means innovating for harm reduction, demonstrating those innovations with robust science, communicating that evidence to both the regulator and the public, and advocating for the regulatory conditions that inform product selections and motivate consumers to switch to safer products.  

ARAC is committed to helping responsible innovators achieve each of these goals. Informed by behavioral-science, our consumer research services help keep consumer needs at the center of product design to ensure that the product will succeed commercially while advancing public health. Our regulatory science services help substantiate manufacturers’ claims that their products are appropriate for the protection of public health. Our peer-reviewed publications, conference presentations and print- and digital media presence disseminates our research findings. And our engagement with the US regulator provides opportunities to advocate for the products that have a demonstrated ability to reduce harm, and the regulatory conditions that support consumer transitions away from riskier forms to tobacco to these safer alternatives.  

At a time when adult smoking rates are falling and youth use of any tobacco or  nicotine product is at an all time low, it would be easy to assume smoking is no longer the societal problem it once was. But more than 480,000 Americans still die each year from smoking-related diseases (Centers for Disease Control and Prevention [CDC], 2024) - a toll roughly the size of metropolitan Miami. The need for accessible, regulated alternatives remains as urgent as ever. This moment matters. Now is the time for credible, consumer-minded innovators to set the standard for what responsible harm reduction looks like; and for regulators to create the conditions for these innovators to succeed. ARAC is here to help.