Candice Horbacz
Last week, President Trump formally nominated Dr. Heidi Overton, a prominent White House domestic policy aide, to assume the critical role of Commissioner of the Food and Drug Administration (FDA). Should her nomination be confirmed by the Senate, Dr. Overton will inherit an agency grappling with complex public health challenges, none more pressing than the urgent need for comprehensive reform within its Center for Tobacco Products (CTP). This appointment comes at a pivotal moment, as debates intensify over how best to regulate nicotine products, balance public health imperatives with consumer choice, and foster innovation in harm reduction strategies.
The FDA, a cornerstone of public health protection in the United States, is responsible for safeguarding public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Crucially, it also regulates tobacco products. Within this broad mandate, the CTP holds specific authority over the manufacturing, marketing, and distribution of tobacco products, a responsibility granted by the Family Smoking Prevention and Tobacco Control Act of 2009. This landmark legislation empowered the FDA to regulate tobacco products for the first time, aiming to reduce tobacco-related death and disease. However, two decades of CTP policy decisions have inadvertently created a complex regulatory quagmire, fostering significant problems within the very industries it seeks to oversee and impacting public health outcomes.
The Unintended Consequences of Restrictive Policies
A central critique leveled against the CTP’s regulatory approach has been its stifling effect on harm reduction. Policies, particularly those governing premarket authorization, have demonstrably suppressed the availability and accessibility of alternative tobacco products (ATPs). These ATPs, which include e-cigarettes, heated tobacco products, and modern oral nicotine pouches, are widely acknowledged by a growing body of scientific evidence to be significantly less harmful than traditional combustible cigarettes. Combustible cigarettes remain the leading cause of preventable death in the United States, responsible for approximately 450,000 fatalities annually and contributing to an estimated $300 billion in healthcare costs and lost productivity each year.
The foreseeable unintended consequences of these restrictive policies have been manifold. By limiting legal, less harmful alternatives, the CTP has inadvertently driven a substantial segment of the consumer base towards unregulated and often dangerous illicit markets. This dynamic not only undermines the public health goal of reducing exposure to harmful substances but also creates a significant challenge for law enforcement and results in widespread tax noncompliance, diverting essential revenue from public services.
Recent Progress and the Path Forward
While the challenges are substantial, the CTP has demonstrated glimmers of progress in recent years. In 2025, the Center commendably reduced the backlog of Premarket Tobacco Product Applications (PMTAs) by approximately 70 percent, a crucial step towards addressing years of regulatory inertia. Building on this momentum, the CTP has accelerated PMTA reviews further in the current year and introduced some flexibility for products currently under review but not yet officially authorized for marketing. This newfound efficiency, though welcome, represents only the initial phase of the comprehensive reforms that many stakeholders argue are desperately needed.
Reforming the Burdensome PMTA Process
At the heart of the regulatory conundrum lies the PMTA process. In the United States, any company seeking to offer a new nicotine product for public sale must first secure a marketing granted order (MGO) from the FDA. To obtain this permission, manufacturers are tasked with demonstrating that their product is "appropriate for the protection of public health." This seemingly straightforward requirement has, in practice, evolved into an extraordinarily burdensome and costly undertaking.
The process demands a separate application for each distinct product, or "SKU" (stock keeping unit), meaning that a line of similar products with slight variations in flavor or nicotine strength can incur exponentially higher costs. The FDA’s initial estimate for a single PMTA for electronic cigarettes or other novel tobacco products was approximately $333,000. However, industry reports and legal challenges have revealed that the actual costs can run into several million dollars per SKU, escalating to over $100 million for an entire product line. This financial barrier disproportionately impacts smaller manufacturers and start-ups, fostering market consolidation and significantly limiting product innovation and consumer choice. Even with the FDA’s underestimated figures, the agency itself acknowledged that the PMTA process would lead to "additional product exit, consolidation, and reduction in variety."
From a public health perspective, burdening the industry for reduced-harm tobacco products is counterproductive. It not only damages legitimate businesses but, more critically, undermines public health objectives by suppressing the very products that public health experts advocate for as alternatives for adult smokers unable or unwilling to quit nicotine entirely.
To build upon the CTP’s recent strides in streamlining the PMTA process, Dr. Overton’s leadership could champion the establishment of a specific fast-track pathway for products unequivocally known to be less harmful than combustible cigarettes. This category would include e-cigarettes, heat-not-burn devices, and nicotine pouches. While many of these products are relatively nascent in the U.S. market, they are well-established and widely accepted as harm-reduction tools in numerous international markets, such as the United Kingdom and Sweden, where public health agencies actively encourage their use as alternatives to smoking.
Furthermore, the existing PMTA timeline is often honored in the breach. The CTP is officially "supposed" to render a decision within 180 days of receiving an application, yet historically, there have been no substantive consequences for failing to meet this deadline. This lack of accountability creates immense uncertainty for manufacturers and delays the availability of potentially life-saving products for consumers. A critical reform would be to implement a conditional approval mechanism: any PMTA that does not receive a definitive decision within the 180-day window should be provisionally approved, allowing market access while the review continues. This would create a powerful incentive for the CTP to act expeditiously and decisively. To prevent the CTP from resorting to perfunctory reviews followed by blanket denials—a practice that has led to legal challenges, including a recent case heard by the Supreme Court concerning flavored e-cigarettes—the agency must also be mandated to increase transparency. This includes issuing specific, detailed guidance on the rationale behind both rejections and approvals, providing clarity for future applicants and fostering a more predictable regulatory environment.
Establishing Transparent Processes and Criteria for Approval
A fundamental improvement to the review process would be to dramatically enhance transparency by clearly defining the requirements for approval, consistently adhering to them, and providing explicit guidance on the criteria used to accept or deny applications. The nebulous standard of "appropriate for the protection of public health" demands greater specificity. What exact types of studies, epidemiological evidence, and scientific data are required to satisfy this criterion? How are these diverse forms of evidence weighted and evaluated?
The Supreme Court recently ruled that the FDA possesses the legal authority to issue guidance, modify its requirements retroactively, and even issue blanket denials for applications that fail to meet these new, evolving standards. While legally permissible, this does not imply that such practices are prudent or conducive to sound public health policy. Indeed, such regulatory capriciousness fosters distrust, stifles innovation, and creates an untenable environment for legitimate businesses. The CTP does not require a court order to institute beneficial reforms; however, a recent Fifth Circuit ruling regarding its processes suggests that judicial intervention may yet compel greater clarity and fairness.
The establishment of a clearly defined, publicly accessible set of standards for authorizing or denying new product applications is paramount. The current landscape, where various types of studies and trials are requested without clear guidelines on their evaluation, is inefficient and opaque. A comprehensive set of standards would not only alleviate the burden on PMTA applicants but also provide crucial guidance for future product development and innovation, ensuring that manufacturers can design products and conduct research aligned with regulatory expectations. Coupled with clear explanations for decision-making, such reforms would significantly boost transparency and efficiency, benefiting both industry and public health.
Addressing the Ongoing Vaping Market Disaster
The current state of the U.S. vaping market can accurately be described as a disaster, largely a direct consequence of the FDA’s restrictive authorization policies. To date, the FDA has authorized a mere handful of e-cigarette brands—only five at the time of this writing—to legally market their products in the United States. This severe lack of legal, regulated options has created an enormous vacuum, which has been enthusiastically filled by a burgeoning and dangerous illicit market.
Historically, the CTP has denied the vast majority of e-cigarette applications. While recent approvals signal a slight shift, legal sales still struggle to compete against the pervasive illicit market. A recent study estimated that a staggering 69.4 percent of all e-cigarette sales in the U.S. comprise unauthorized products. This figure skyrockets to an alarming 97.6 percent for disposable vaping systems and reaches a near-absolute 100 percent for flavors other than tobacco or menthol—flavors for which the FDA has, controversially, maintained a de facto blanket denial policy, despite evidence suggesting their role in helping adult smokers transition away from combustible cigarettes.
The demand for illicit products is a direct function of the scarcity of legal alternatives. Dr. Overton’s leadership could pivot the CTP towards authorizing a broader array of vapor products, thereby enabling the establishment of a robust, competitive legal market capable of displacing the illicit market’s long-standing dominance.
Bringing consumers into the legal market offers significant advantages beyond preventing widespread tax noncompliance. Illicit products, by their very nature, evade all regulatory oversight throughout their manufacturing processes. They are often produced in unregulated facilities, may contain undisclosed or harmful ingredients, and offer no accountability in the event of consumer injury. Legal products, conversely, are subject to manufacturing standards, ingredient disclosure, and quality control, offering a far safer option for consumers.
Once a viable legal market is established to compete effectively, enforcement efforts against illicit products—many of which are smuggled from China—would become substantially more effective. In September 2025, the FDA and U.S. Customs and Border Protection announced the largest-ever seizure of unauthorized e-cigarettes, valued at approximately $86.5 million. While this was a significant sum for a single operation, it remains a mere drop in the bucket compared to the vast, multi-billion-dollar illicit product industry that continues to flourish. Enforcement alone, however vigorous, remains largely futile in the absence of an adequate and accessible legal market. If the CTP genuinely aims to reduce the prevalence of dangerous illicit products in the U.S., it must facilitate legal activity by authorizing more products, thereby empowering enforcement efforts to achieve meaningful, lasting impact.
Evaluating the Risks and Realities of Youth Use
A key priority for the CTP, and an undeniably important consideration in regulating nicotine products, is discouraging youth nicotine use. While this concern is reasonable and legitimate, the CTP must adopt a more nuanced and realistic evaluation of the actual risks of youth consumption, informed by the latest data.
Encouragingly, youth use of vapor products continues a promising downward trend. The FDA’s 2025 National Youth Tobacco Survey (NYTS) reported that only 5.2 percent of middle and high school students reported current use of vapor products. This represents a significant decline from 5.9 percent in 2024 and 9.4 percent in 2022. For context, the 2025 National Survey on Drug Use and Health (NSDUH) found that 8.7 percent of adolescents used marijuana, a significantly higher rate of youth use than vaping. While it remains possible that some high school students underreport vapor usage, the FDA has historically used NYTS data to justify actions to curb youth usage; therefore, it should appropriately adjust its policy considerations as that data evolves and demonstrates declining trends.
The overall trend in youth tobacco product use is extremely positive, indicating that youth usage of ATPs is far from the crisis levels often portrayed. While continued monitoring of youth usage is essential, this consistent decline should be thoughtfully incorporated into the CTP’s evaluations of product risks when reviewing applications. As the perceived and actual risks of youth use diminish, the net public health benefits of promoting harm-reducing ATPs for adult smokers grow significantly.
The Broader Public Health Imperative and Dr. Overton’s Challenge
The ultimate public health imperative for the FDA and its Center for Tobacco Products is to sharply reduce the staggering toll of 450,000 annual deaths directly attributable to smoking in the U.S. This remains a solvable crisis, and the strategic enablement of a robust, well-regulated market for less harmful alternative products is a powerful, evidence-based pathway to achieving this goal.
The CTP has, as noted, taken initial, undeniable steps toward desperately needed reforms. However, these are merely foundational. The scale of the challenge and the potential for public health improvement demand much more. Dr. Heidi Overton’s impending leadership at the FDA presents a critical opportunity. Her tenure could mark a transformative shift in the agency’s approach to tobacco regulation, moving from a primarily prohibitive stance to one that strategically leverages harm reduction.
This would involve not only streamlining and rationalizing the PMTA process but also fostering greater transparency, actively combating the illicit market through the promotion of legal alternatives, and adopting a data-driven, balanced perspective on youth use that acknowledges declining trends while remaining vigilant. Public health advocates, industry stakeholders, and consumers will be closely watching Dr. Overton’s confirmation hearings and initial actions. Public health organizations, while generally supportive of strong regulation to protect youth, often express concerns about potential industry influence and the risk of new nicotine addiction pathways. Conversely, harm reduction advocates and industry players will likely press for policies that prioritize adult access to less harmful alternatives and create clear, predictable regulatory pathways.
The successful implementation of these reforms under Dr. Overton’s guidance could save countless lives, significantly reduce the economic burden of smoking-related diseases, and establish functioning markets for harm-reducing alternative products, ultimately charting a more effective course for tobacco control in the United States.
