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, not least among them the critical need for comprehensive reform within its Center for Tobacco Products (CTP). The CTP, established following the landmark Family Smoking Prevention and Tobacco Control Act of 2009, is tasked with regulating tobacco products to protect public health, yet its policy decisions over the past two decades have inadvertently created significant problems in the very industries it oversees, particularly concerning alternative tobacco products (ATPs). These challenges, ranging from an overburdened product review process to the proliferation of illicit markets, demand urgent and strategic attention from the incoming leadership.
The Genesis of FDA’s Tobacco Authority and the CTP’s Mandate
The FDA’s authority to regulate tobacco products was significantly expanded with the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009. This pivotal legislation granted the FDA power over the manufacturing, marketing, and distribution of tobacco products, aiming to reduce tobacco-related disease and death. A key component of this act was the establishment of the Center for Tobacco Products (CTP), specifically designed to implement the new regulatory framework. Initially, the CTP’s focus was primarily on traditional combustible cigarettes and smokeless tobacco. However, the regulatory landscape shifted dramatically with the advent and rapid rise of electronic nicotine delivery systems (ENDS), or e-cigarettes, and other novel products like heat-not-burn devices and nicotine pouches.
In May 2016, under the "deeming rule," the FDA extended its regulatory authority to include all tobacco products, including e-cigarettes, cigars, pipe tobacco, and other nicotine-containing products. This expansion mandated that manufacturers of these newly deemed products submit Premarket Tobacco Product Applications (PMTAs) to the FDA to continue marketing their products. The intent was to ensure that these products met public health standards before being widely available. However, this regulatory expansion, while well-intentioned, laid the groundwork for many of the issues the CTP faces today, particularly the bottleneck in the PMTA review process and the subsequent impact on innovation and market dynamics. The initial deadline for PMTA submissions was extended multiple times, ultimately settling on September 9, 2020, for many products, triggering an unprecedented wave of applications.
The PMTA Process: A Barrier to Harm Reduction and Innovation
Central to the CTP’s regulatory framework is the Premarket Tobacco Product Application (PMTA) process. Companies seeking to offer new nicotine products for sale in the U.S. must first secure a marketing granted order (MGO) from the FDA. This requires manufacturers to demonstrate that their product is "appropriate for the protection of public health," a broad criterion that necessitates extensive scientific evidence. While the objective is sound—to ensure product safety and public health benefit—the execution of the PMTA process has become a formidable barrier for manufacturers, particularly those developing reduced-harm alternative products.
The financial and logistical burden of PMTAs is immense. The FDA’s initial estimates for the cost of a PMTA for electronic cigarettes or other novel tobacco products were around $333,000. However, actual costs have reportedly escalated significantly, reaching several million dollars per individual stock-keeping unit (SKU), and potentially exceeding $100 million for an entire product line with various flavors and nicotine strengths. This exponential cost is driven by the requirement for comprehensive studies covering toxicology, chemistry, product design, manufacturing processes, and extensive behavioral research on potential youth appeal and adult cessation rates. Each distinct product variation—even a different flavor of the same device—often requires a separate application, compounding the expense.
This exorbitant cost structure has profound implications. As the FDA itself acknowledged when first estimating these costs, such a burden was expected to lead to "additional product exit, consolidation, and reduction in variety" within the industry. Industry stakeholders, particularly smaller businesses and innovators in the ATP sector, have voiced concerns that these costs stifle competition and innovation. From the perspective of public health, this suppression of reduced-harm products is counterproductive. If smokers are to switch to demonstrably less harmful alternatives like e-cigarettes, heat-not-burn products, or nicotine pouches, these products must be readily available, diverse, and competitive with traditional cigarettes. By making the approval process prohibitively expensive and arduous, the CTP inadvertently undermines its own public health mission by limiting access to products that could save lives.
Recent Progress and the Imperative for Further Reform
Despite these systemic challenges, the CTP has made notable strides in recent years, demonstrating a capacity for improvement that Dr. Overton can build upon. In 2025, the CTP successfully reduced its significant backlog of PMTAs by approximately 70 percent, a crucial step towards addressing the bottleneck that had plagued the industry for years. This year, the CTP has further accelerated PMTA reviews and even allowed some leeway for products under review but not yet officially authorized to remain on the market, offering a glimmer of hope to manufacturers. These "recent successes," as highlighted by the CTP’s acting director, indicate a recognition within the agency of the need for greater efficiency and responsiveness.
However, many industry groups and public health advocates argue that this progress, while welcome, is insufficient. They contend that the agency’s current trajectory, even with improved efficiency, does not fully address the underlying issues of the PMTA process. One critical area for reform is the establishment of a specific fast-track process for products scientifically proven to be less harmful than combustible cigarettes. Many ATPs, while relatively new to the U.S. market, are well-established in other countries with robust regulatory frameworks, providing a wealth of data on their comparative risks. A streamlined pathway for such products could accelerate their availability, offering smokers more viable alternatives sooner.
Another significant concern revolves around the lack of a firm timeline for PMTA decisions. While the CTP is "supposed" to render a decision within 180 days, there are no stipulated consequences for failing to meet this deadline. This lack of accountability leaves manufacturers and consumers vulnerable to prolonged uncertainty and economic damage. To instill a genuine incentive for timely action, proposals from industry groups often suggest that any PMTA that does not receive a decision within the 180-day window should be conditionally approved. This "deemed approved" mechanism would shift the burden of inaction back to the CTP and ensure that innovative products are not perpetually trapped in regulatory limbo. To prevent the CTP from simply issuing blanket denials in response to such a rule, enhanced transparency in the review process and clear, specific guidance on the reasons for rejection or approval are also deemed essential.
Enhancing Transparency and Defining Clear Approval Criteria
A major point of contention within the PMTA process is the perceived lack of transparency regarding approval criteria. Manufacturers often grapple with an ambiguous definition of what it means for a product to be "appropriate for the protection of public health" and precisely what types of studies or evidence are required to demonstrate this. This ambiguity creates a moving target for companies investing millions in applications, leading to frustration and, often, rejection.
The legal landscape surrounding this issue is complex. The Supreme Court recently clarified that the FDA is allowed to issue guidance, change its requirements, and even deny applications based on new criteria. However, legal permission does not equate to sound public policy or effective regulatory practice. Critics argue that such broad discretion without clear, pre-defined standards can lead to arbitrary decision-making and a lack of predictability for an industry attempting to navigate a highly regulated environment. A recent Fifth Circuit ruling further underscores the legal scrutiny the CTP’s processes are facing, indicating that judicial intervention might compel reforms if internal changes are not forthcoming.
For Dr. Overton, a clear priority should be to establish a transparent, well-defined set of standards for authorizing or denying new product applications. Currently, manufacturers report that various types of studies and trials are requested, but there is often little clarity on how these are evaluated or what specific benchmarks must be met. A standardized framework would not only streamline the PMTA process and reduce the burden on manufacturers but also provide invaluable guidance for future product development and innovation. This would allow companies to design products and conduct research with a clearer understanding of the FDA’s expectations, fostering a more efficient and predictable regulatory environment. Furthermore, providing detailed explanations for approval or denial decisions would enhance transparency, build trust, and allow manufacturers to refine their products and applications more effectively.
Addressing the Vaping Market Disaster: The Rise of Illicit Products
The CTP’s restrictive approach to authorizing alternative tobacco products, particularly e-cigarettes, has inadvertently fueled a burgeoning illicit market. To date, the FDA has authorized a very limited number of e-cigarette brands to be legally sold in the U.S. This severe lack of legal options has created a vacuum that unauthorized products, many of which are flavored, have eagerly filled. A recent study estimated that a staggering 69.4 percent of e-cigarette sales in the U.S. were unauthorized products. This figure skyrockets to 97.6 percent for disposable systems and reaches 100 percent for flavors other than tobacco or menthol—categories for which the FDA has largely issued blanket denials.
This "vaping market disaster" is primarily a consequence of regulatory bottlenecks. Consumer demand for a variety of products, particularly flavored options which many adult smokers find essential for transitioning away from cigarettes, has not diminished. When legal avenues are blocked, consumers inevitably turn to the illicit market. This phenomenon has several detrimental consequences beyond widespread tax noncompliance, which itself costs states millions in lost revenue. Illicit products are consistently more dangerous to consumers than their legally regulated counterparts. They often bypass critical regulatory requirements in manufacturing, leading to inconsistent product quality, undisclosed or harmful ingredients, and unreliable nicotine concentrations. Furthermore, consumers injured by illicit products have little to no recourse, as these manufacturers operate outside the legal framework.
Bringing consumers into a regulated legal market is paramount for public health and safety. If the CTP were to authorize a wider array of vapor products, it would allow a robust legal market to emerge and directly compete with, and eventually displace, the illicit market that currently dominates. Such a shift would also make enforcement efforts significantly more effective. While agencies like the FDA and Customs and Border Protection (CBP) have ramped up their efforts—evidenced by the September 2025 announcement of the largest-ever seizure of unauthorized e-cigarettes, valued at approximately $86.5 million—these seizures represent a mere "drop in the bucket" compared to the vast, multi-billion-dollar industry of illicit products, many of which are smuggled from China. Enforcement, while important, remains largely futile when there isn’t an adequate legal market to replace the illicit activity. Dr. Overton’s leadership could redefine this strategy by balancing enforcement with expanded legal access.
Re-evaluating Youth Use: Balancing Protection with Harm Reduction
One of the CTP’s primary concerns, and understandably so, is discouraging youth nicotine use. This is a reasonable and undeniably important consideration when regulating tobacco products. However, critics argue that the CTP should more realistically evaluate the risks of youth consumption in the context of the evolving data and the overarching goal of adult harm reduction.
Recent data paints a promising picture regarding youth vapor product use. 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 significant decline from 5.9 percent in 2024 and 9.4 percent in 2022. While youth usage should continue to be monitored vigilantly, this downward trend indicates that youth usage of ATPs is far from the "epidemic" levels often cited in previous years, when rates peaked around 2019. For context, the 2025 National Survey on Drug Use and Health found that 8.7 percent of adolescents reported using marijuana, a significantly higher rate than current vaping usage. While some argue that high school students might underreport vapor usage, the FDA itself utilizes this data to justify its regulatory actions, suggesting it should also adjust its policies when the data indicates positive changes.
This trend of declining youth use should be robustly incorporated into the CTP’s evaluations of product risks when reviewing PMTAs. As the risks of youth initiation decline, the net public health benefits of widely available, harm-reducing ATPs for adult smokers become even more pronounced. The CTP’s mandate is to protect public health broadly, which includes both preventing youth initiation and facilitating adult cessation from deadly combustible cigarettes.
Smoking remains a monumental public health crisis in the United States, responsible for an estimated 450,000 deaths annually. The FDA and the CTP possess the tools and authority to sharply reduce this devastating toll by enabling the sale of less harmful alternative products. The CTP has taken undeniable, albeit incremental, steps toward desperately needed reforms in its processes. However, under Dr. Overton’s new leadership, there is an opportunity for more transformative change. By establishing more efficient, transparent, and responsive markets for harm-reducing alternative products, the CTP can more effectively fulfill its core mission: to protect and improve public health, ultimately saving countless lives. The path forward for Dr. Overton will require a delicate balance of protecting the vulnerable, fostering innovation, and addressing the unintended consequences of past policies.
