The direction of federal vapor product regulation in the United States hangs in the balance following leadership changes within the U.S. Department of Health and Human Services. While many vapers and industry advocates welcome the departure of certain vocal anti-vaping officials, a sense of uncertainty prevails. Meaningful policy reform is still needed to translate President Trump’s renewed commitment to "save flavored vaping" into tangible reality for millions of American adults who rely on these products. The current regulatory framework, critics argue, remains deeply flawed, hindering access to potentially life-saving alternatives to combustible cigarettes.
Vaping's Emergence Coincides with Record Low Smoking Rates
Despite being commercially available for nearly two decades, electronic cigarettes and nicotine vapor products face ongoing condemnation from influential public health groups, numerous policymakers, and a significant portion of the public. This persistent opposition exists even as their market presence has directly paralleled a dramatic, historic reduction in cigarette smoking among American adults. This shift marks a stark departure from the mid-century "Mad Men" era where tobacco advertising reigned supreme. Underscoring this trend, the U.S. Centers for Disease Control and Prevention (CDC) highlighted in a March 2025 Morbidity and Mortality Weekly Report that “adult cigarette smoking prevalence remains at its lowest level in 60 years.” While some conventional tobacco control measures, like targeted taxes or public use restrictions, likely contributed, proponents of harm reduction argue that the introduction and adoption of innovative vaping technology correlates with the most significant declines in deadly combustible cigarette use. They posit that offering smokers less harmful ways to consume nicotine is a powerful public health tool.
A History Rooted in Harm Reduction, Not Big Tobacco
Challenging popular anti-vaping rhetoric, the modern e-cigarette was not a creation of Big Tobacco aimed at addicting a new generation. Its origins trace back to Hon Lik, a Chinese pharmacist seeking a less harmful alternative to smoking, effectively inventing it as a smoking cessation device. Since entering the U.S. market around 2007, e-cigarettes have undergone significant evolution driven largely by independent companies responding to consumer needs. Initial "cigalikes" mimicking traditional cigarettes gave way to more powerful, customizable "open system" devices, followed by convenient "pod mods," and most recently, the ubiquitous disposable vapes. It wasn't until 2012, a full five years after vaping's US debut, that a major tobacco company made its first significant move by acquiring the blu brand. The landscape truly shifted when the FDA asserted regulatory authority over e-cigarettes as tobacco products, a move upheld by courts, leading to the 2016 "deeming rule." Only then did Big Tobacco begin introducing its own vaping products, navigating a complex and often ambiguous regulatory pathway.
The PMTA Gauntlet: Stifling Innovation, Favoring Giants
Before this federal oversight intensified, American vapor manufacturers operated with agility, quickly adapting products based on user feedback and technological advancements. The 2016 deeming rule, however, implemented the burdensome Premarket Tobacco Product Application (PMTA) process. This regulation mandated that all vaping products introduced after February 15, 2007, undergo rigorous, expensive FDA review and receive explicit marketing authorization before being legally sold. Critics describe the PMTA process as a nearly insurmountable barrier for the small and medium-sized independent businesses that pioneered the industry. The extensive data requirements and high costs associated with submitting a PMTA created a regulatory bottleneck that effectively stifled innovation and favored companies with deep pockets – namely, Big Tobacco.
The results are stark: As of April 1, 2025, the FDA had authorized only 34 vapor products for sale nationwide. Tellingly, all these authorized products are owned by just three major tobacco corporations, entities that continue to derive substantial profits from selling the very combustible cigarettes vaping aims to replace. Furthermore, the agency continues to authorize far more new combustible cigarette products than innovative, potentially harm-reducing vapor alternatives.
The Tobacco Control Act: The Underlying Hurdle?
While changes in FDA leadership or enforcement priorities might offer temporary shifts, many argue the fundamental problem lies within the 2009 Family Smoking Prevention and Tobacco Control Act (TCA). This legislation, championed by Senator Dick Durbin (D-Ill.)—a long-standing opponent of both traditional tobacco and vaping products—imposes severe limitations on adult access to reduced-risk nicotine alternatives. Any product launched after the 2007 predicate date faces the daunting PMTA pathway. In the decade-plus since its implementation, a mere 76 novel tobacco/nicotine products (including those 34 vape products) have successfully navigated this process, compared to the thousands of combustible cigarette products grandfathered in or approved through less stringent pathways.
Global Harm Reduction Acceptance vs. US Hesitancy
During President Trump’s first term, FDA leadership expressed some recognition of tobacco harm reduction's potential. However, under the subsequent Biden administration, this forward momentum appeared to stall, replaced by a more prohibitive stance. This contrasts sharply with public health approaches in other developed nations. Health bodies in Canada, the United Kingdom, and New Zealand, among others, publicly acknowledge that e-cigarettes are significantly less harmful than combustible cigarettes. Some, like Public Health England (now the Office for Health Improvement and Disparities), have actively encouraged adult smokers unable to quit nicotine entirely to switch to vaping. Yet, the US regulatory environment largely remains entrenched in what critics call a regressive, fear-based mindset that downplays or ignores the potential benefits for adult smokers.
Allegations of Disinformation and Market Capture
This policy stagnation, some contend, may also reflect the increasing influence of Big Tobacco companies within the regulatory sphere. Critics allege these companies, having gained the President's ear, have engaged in spreading misinformation – ranging from amplifying fears about youth vaping (often used to justify flavor bans that disproportionately affect adult smokers) to promoting sensationalist claims about illicit fentanyl-laced vapes from China. Concurrently, state legislatures nationwide are advancing "vapor product registry" bills. While often framed as state-level enforcement tools, these bills frequently restrict sales to only those products that have received federal PMTA authorization – effectively locking out competitors and handing the market to the few Big Tobacco companies whose products dominate the short list of FDA-approved vapes, all enforced at taxpayer expense.
The Overlooked Adult Vaper and the Call for Reform
Big Tobacco, though late to innovate in the vapor space, shouldn't necessarily be barred from offering potentially safer nicotine alternatives. However, critics argue vehemently against allowing them to monopolize a grassroots harm reduction movement initiated by former smokers and independent entrepreneurs. The demographic reality is that among adults aged 25 and older who vape, the vast majority are either current or, more often, former smokers specifically seeking a less dangerous way to consume nicotine. Yet, hampered by outdated legislation like the TCA and a federal regulatory framework seemingly detached from real-world science and consumer behavior, these adults face growing uncertainty and shrinking access to the products, particularly the flavors, that helped them quit smoking.
President Trump made a clear promise to protect flavored vaping options. With over 20 million adult vapers in America – many of whom are former smokers potentially saved from returning to deadly cigarettes – the expectation for decisive action and meaningful regulatory reform is immense. They await policies that acknowledge harm reduction, foster responsible innovation, and prioritize the needs of adults seeking safer alternatives.
