Candice Horbacz
Last week, President Trump nominated White House domestic policy aide Dr. Heidi Overton to become the new Commissioner of the Food and Drug Administration (FDA). If confirmed by the Senate, Dr. Overton will step into an agency grappling with complex public health challenges, none more pressing than the need for significant reform within its Center for Tobacco Products (CTP). The CTP, established with the critical mandate to protect public health by regulating tobacco products, has faced increasing scrutiny over policies that critics argue have inadvertently stifled harm reduction and fueled a burgeoning illicit market.
The FDA’s Mandate and the Genesis of the CTP
The FDA, a federal agency of the Department of Health and Human Services, is responsible for protecting public health by assuring 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. Its regulatory reach extends to tobacco products, a responsibility solidified by the landmark Family Smoking Prevention and Tobacco Control Act (TCA) of 2009. This act granted the FDA authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors.
The establishment of the CTP within the FDA was a direct outcome of the TCA. Its primary objective was to oversee a vast and evolving landscape of tobacco products, from traditional cigarettes to novel nicotine delivery systems like e-cigarettes and nicotine pouches. A cornerstone of the CTP’s regulatory framework is the Premarket Tobacco Product Application (PMTA) process. This rigorous pathway requires manufacturers to demonstrate that any new tobacco product is "appropriate for the protection of public health" before it can be legally marketed in the United States. This determination involves considering the risks and benefits to the population as a whole, including users and non-users, and assessing the likelihood of initiation and cessation.
Unintended Consequences and the Harm Reduction Dilemma
Over the past two decades, however, many CTP policy decisions have been criticized for creating serious, and arguably foreseeable, problems within the industries it regulates. A central critique revolves around the agency’s approach to alternative tobacco products (ATPs), such as e-cigarettes, heat-not-burn devices, and nicotine pouches. These products are widely recognized by many public health experts as significantly less harmful than traditional combustible cigarettes, which are responsible for approximately 450,000 deaths annually in the U.S.
The concept of harm reduction in tobacco control advocates for policies that minimize the negative health effects of tobacco use when complete cessation is not achievable. For millions of adult smokers unable or unwilling to quit nicotine entirely, switching to less harmful ATPs represents a substantial public health gain. However, critics argue that the CTP’s stringent, often opaque, and lengthy regulatory processes have inadvertently suppressed the availability of these potentially life-saving alternatives. By making it exceedingly difficult and costly for manufacturers to bring ATPs to market, the CTP has, according to some analyses, curtailed innovation and limited legal options for consumers seeking to move away from cigarettes. This has, in turn, inadvertently pushed a significant segment of consumers towards illicit, unregulated products, further complicating public health efforts.
The Burdensome PMTA Process: Costs, Delays, and Lack of Transparency
The PMTA process is at the heart of the regulatory quagmire. Manufacturers seeking to offer nicotine products for sale must first secure a marketing granted order (MGO) from the FDA. This involves submitting extensive scientific evidence to demonstrate that the product is "appropriate for the protection of public health." The sheer complexity and cost associated with this process have become a major barrier, particularly for smaller businesses and novel products.
Initially, the FDA estimated the cost of a PMTA for electronic cigarettes or other novel tobacco products to be around $333,000. However, actual costs have reportedly escalated to several million dollars per individual product SKU (Stock Keeping Unit), potentially exceeding $100 million for a comprehensive product line. These exorbitant costs are driven by the requirement for extensive toxicological studies, clinical trials, behavioral research, and detailed marketing plans. Even with the FDA’s initial underestimated figures, the agency acknowledged that such costs would lead to "additional product exit, consolidation, and reduction in variety."
This burden on the reduced-harm tobacco product industry not only harms businesses but, more critically, undermines public health. By limiting the availability and variety of less harmful alternatives, it restricts the choices available to adult smokers who might otherwise transition away from deadly combustible cigarettes. The lack of a clear, predictable, and timely review process further exacerbates the problem. While the CTP is theoretically supposed to render a decision within 180 days of application submission, there have historically been no significant consequences for failing to meet this deadline. This lack of accountability has led to heavily protracted review processes, leaving manufacturers and consumers in a state of uncertainty.
Recent Progress and Calls for Further Reform
Amidst the criticisms, the CTP has made some notable strides. In 2025, the agency successfully reduced its significant backlog of PMTAs by approximately 70 percent, a testament to internal efforts to streamline operations. This year, the CTP has continued to accelerate PMTA reviews and has even allowed some leeway for products currently under review but not yet officially authorized, indicating a pragmatic shift in approach.
While this progress is encouraging, advocates for reform argue that much more can be done. Dr. Overton’s confirmation presents a critical opportunity to build upon these successes and implement more systemic changes:
- Fast-Track Process for Less Harmful Products: A key proposal is to establish a specific fast-track process for products scientifically demonstrated to be significantly less harmful than cigarettes, such as e-cigarettes, heat-not-burn products, and nicotine pouches. Many of these ATPs are already well-established and regulated in other sophisticated markets globally, providing a robust body of evidence for their comparative risk profiles.
- Conditional Approval for Delayed Applications: To incentivize timely action by the CTP and protect against indefinite delays, a mechanism for conditional approval has been suggested. Any PMTA that does not receive a definitive decision within the 180-day statutory window could be conditionally approved for market entry, subject to ongoing review and the possibility of future recall if deemed necessary. This would shift the burden of inaction from manufacturers to the agency, fostering greater efficiency. To prevent the CTP from merely issuing blanket denials without substantive review, such conditional approvals would need to be coupled with enhanced transparency requirements.
Establishing Transparent Processes and Clear Approval Criteria
A major point of contention has been the perceived lack of transparency and clear criteria in the PMTA review process. What precisely constitutes "appropriate for the protection of public health" often remains nebulous, and the types of studies or evidence required to demonstrate this have varied. Manufacturers frequently report receiving requests for different or additional data points late in the review cycle, leading to further delays and increased costs.
The Supreme Court recently ruled that the FDA is allowed to issue guidance, change its requirements after the fact, and even deny applications for not meeting new, uncommunicated criteria. While legally permissible, this approach undermines predictability and fair process. A recent Fifth Circuit ruling on the CTP’s process further underscores the judicial scrutiny the agency faces regarding its procedural fairness.
To foster a more predictable and equitable regulatory environment, the CTP should:
- Define Clear Standards: Establish a clearly defined set of standards for authorizing or denying new product applications. This would include outlining the specific types of studies, methodologies, and evidence thresholds required for different product categories.
- Publish Evaluation Methodologies: Provide clear guidance on how different types of evidence, such as toxicology, clinical, and behavioral studies, are evaluated and weighted in the decision-making process.
- Issue Specific Justifications: When applications are rejected or approved, the CTP should be required to issue specific, detailed guidance explaining the rationale behind its decision. This would not only enhance transparency but also help guide future product development and innovation by providing manufacturers with actionable feedback.
Addressing the Ongoing Vaping Market Disaster and Illicit Trade
The restrictive approach to PMTA approvals has had profound consequences for the U.S. vaping market, creating what many describe as a "disaster" characterized by a dominant illicit trade. To date, the FDA has authorized only a handful of e-cigarette brands (five as of early 2026) to legally sell their products in the U.S. This severe lack of legal options has inevitably pushed millions of consumers into the unregulated, illicit market.
A recent study estimated that "only" 69.4 percent of e-cigarette sales in the U.S. were unauthorized products, a figure that dramatically rises to 97.6 percent for disposable systems and a staggering 100 percent for flavors other than tobacco or menthol—categories for which the FDA has largely issued blanket denials. This robust demand for illicit products is a direct consequence of the scarcity of legal alternatives. These unauthorized products often bypass crucial regulatory requirements in manufacturing, leading to inconsistent quality, undisclosed ingredients, and greater potential health risks for consumers. Furthermore, the prevalence of illicit products leads to widespread tax noncompliance, depriving states of significant revenue.
Bringing consumers into a well-regulated legal market offers multiple benefits:
- Enhanced Consumer Safety: Legal products are subject to manufacturing standards, ingredient disclosure, and quality controls, offering a baseline of safety that illicit products lack.
- Increased Tax Compliance: A thriving legal market allows for effective taxation, providing revenue for public services.
- Effective Enforcement: Enforcement efforts against illegal products become far more effective when consumers have adequate legal alternatives. The FDA, in collaboration with agencies like U.S. Customs and Border Protection (CBP), has engaged in significant seizures, such as the September 2025 operation that confiscated approximately $86.5 million worth of illicit e-cigarettes. While substantial, this amount is considered a "drop in the bucket" compared to the multi-billion-dollar illicit market, much of which is smuggled from China. Without a robust legal market, enforcement alone is largely futile; supply will continue to meet demand through illicit channels.
The CTP should, therefore, accelerate the authorization of more vapor products, particularly those with strong scientific backing for their harm reduction potential. This would enable a legal market to expand, effectively competing with and eventually displacing the illicit market, ultimately enhancing public health and safety.
Evaluating the Risks and Realities of Youth Nicotine Use
A paramount concern for the CTP, and rightly so, is discouraging youth nicotine use. While this is an undeniable priority, critics argue that the agency should more realistically and dynamically evaluate the risks of youth consumption in its regulatory decisions.
Recent data paints a promising picture regarding youth vaping trends. The FDA’s 2025 National Youth Tobacco Survey (NYTS) found that only 5.2 percent of middle and high school students reported current use of vapor products. This represents a continued decline from 5.9 percent in 2024 and 9.4 percent in 2022. For context, the 2025 National Survey on Drug Use and Health reported that 8.7 percent of adolescents used marijuana, a significantly higher rate than current vaping. While acknowledging the potential for underreporting, these trends, which the FDA itself uses to justify action, indicate that youth usage of ATPs is far from a crisis and is, in fact, decreasing.
This positive trend should be a critical factor in the CTP’s evaluations of product risks when reviewing applications. As the perceived risks of youth initiation decline, the net public health benefits of enabling access to harm-reducing ATPs for adult smokers grow. Striking the right balance between preventing youth initiation and facilitating adult cessation is crucial. Overly restrictive policies, while intended to protect youth, can inadvertently harm adult smokers by limiting access to less dangerous alternatives.
The Road Ahead for Dr. Overton and the FDA
Dr. Heidi Overton’s nomination comes at a pivotal moment for the FDA and its Center for Tobacco Products. The agency stands at a crossroads, with opportunities to either reinforce policies that have been criticized for unintended negative consequences or to embrace reforms that could significantly advance public health.
The challenge for Dr. Overton, if confirmed, will be to navigate the complex interplay of public health imperatives, industry innovation, legal scrutiny, and political pressures. She will need to champion reforms that streamline the PMTA process, enhance transparency, effectively address the illicit market, and incorporate a nuanced, data-driven understanding of youth nicotine use.
Ultimately, the FDA and the CTP possess the authority to sharply reduce the annual toll of smoking-related deaths in the U.S. By establishing functioning, well-regulated markets for harm-reducing alternative products, and by ensuring a transparent and efficient regulatory pathway for these innovations, new leadership at the CTP can save countless lives and steer tobacco control policy towards a more effective, harm-reduction-focused future. The success of Dr. Overton’s tenure may well be defined by her ability to lead this crucial transformation.
