Cliff Douglas, a veteran U.S. tobacco control and public health policy expert, said at the NAS 2026 summit that the “continuum of risk” should guide tobacco policy. He advocates for establishing clearer, more predictable pathways for market entry, enhancing communication regarding relative risks, and reflecting risk differentials across products in areas such as regulation, taxation, and enforcement. On potential adjustments to the FDA’s PMTA review process, he views creating a more efficient regulatory pathway for lower-risk products backed by scientific evidence as a “welcome course correction.” Read 2Firsts’ on-site report below.
Key Highlights
- Risk-based Policy: Douglas argues that the “continuum of risk” should be a central principle of tobacco policy, with regulations, taxes, pricing, and enforcement reflecting the varying risk profiles of different products.
- Beyond Litigation: He notes that while litigation was a breakthrough for U.S. tobacco control, the future requires the establishment of a more comprehensive public health and regulatory framework.
- PMTA Reform: Regarding potential FDA adjustments to the PMTA review process, Douglas states that providing a more efficient and predictable regulatory pathway for lower-risk products supported by scientific evidence would be a “welcome course correction.”
- Authorization Is Not the End: He emphasizes that market authorization alone is insufficient to achieve public health goals; accurate risk communication, consumer trust, and effective enforcement are also essential.
- Youth Protection and Harm Reduction: Douglas believes that protecting young people and advancing tobacco harm reduction are not mutually exclusive goals.
Cliff Douglas Urges Risk-Based Tobacco Policy at 2026 Summit
New York, September 25, 2026 – Speaking at the 2026 New Approaches Summit, Cliff Douglas stated that the “continuum of risk” among various tobacco and nicotine products should play a more central role in tobacco policy. Rather than focusing solely on whether or not tobacco products are used, future public health policies should directly address how to reduce population exposure to combustion byproducts and accelerate the replacement of combustible cigarettes with lower-risk alternatives.
Douglas currently heads Tobacco Control Law & Policy Consulting. The New Approaches Summit is being held in New York under the theme “Saving Lives in the 21st Century.” Douglas’s presentation was titled “Beyond Litigation: Building a Public Health Ecosystem to End Smoking.” His remarks focused on regulation, market access, enforcement, risk communication, and the interplay of various public health tools.
President and CEO of the Foundation for a Smoke-Free World
According to biographical information released by the American Cancer Society and Global Action to End Smoking, Douglas has long been involved in tobacco control, public health policy, and tobacco litigation in the United States. He previously served as Vice President for Tobacco Control at the American Cancer Society and provided tobacco policy counsel to the U.S. Assistant Secretary for Health and the Office of the Surgeon General. He also participated—as co-counsel or an expert advisor—in the tobacco litigation brought by U.S. state attorneys general in the 1990s, as well as other significant tobacco-related cases.
In October 2023, Douglas became President and CEO of the Foundation for a Smoke-Free World (later renamed Global Action to End Smoking); according to organizational updates released by the group in 2025, he stepped down from the role that year.
This background explains why Douglas’s perspective on “moving beyond litigation” is noteworthy: rather than evaluating tobacco litigation from outside the legal system, he draws on his extensive experience within the traditional U.S. tobacco control and legal frameworks to argue that litigation must be integrated into a more comprehensive regulatory and public health framework.
Moving from Litigation to a Comprehensive Public Health Regulatory System
Douglas opened his presentation by posing a hypothetical question:
If we were to redesign a tobacco control system today—incorporating our current understanding of smoking, nicotine, combustion, addiction, human behavior, product innovation, and regulation—would the resulting system look anything like the one we have today?
His answer was:
“Absolutely not.”
Douglas pointed out that while combustible cigarettes remain deeply entrenched and easily accessible in the current market, lower-risk alternative products often face uncertain and protracted pathways to legal market entry. Meanwhile, the illicit market is substantial, whereas the regulated, legal market remains relatively limited; furthermore, many consumers and even some healthcare professionals lack a clear understanding of the varying risk profiles associated with different nicotine products.
He stated that if he were to redesign the system, he would prioritize one goal above all else:
- “Reducing population exposure to combustion as rapidly as possible.”
In the subsequent panel discussion, Douglas clarified that “moving beyond litigation” does not mean dismissing the role litigation has played in the history of tobacco control in the United States.
Reflecting on the tobacco litigation of the 1990s, he noted that lawsuits played such a pivotal role partly because other institutional bodies, including the U.S. Congress and state legislatures, had engaged in what he termed an “abdication of responsibility.”
Douglas argued that litigation effectively took place in a “vacuum” when other institutional mechanisms failed to adequately address the smoking epidemic.
At the same time, however, he described those tobacco lawsuits as a “breakthrough.”
He pointed out that litigation does more than establish legal liability; it can also drive subsequent regulatory and policy processes, catalyzing further institutional action.
Incorporating the “Risk Continuum” into Policy Frameworks
Douglas believes that as the nicotine market becomes increasingly diversified, some of the traditional metrics used to measure progress in tobacco control have become too blunt.
During the era when combustible cigarettes dominated the market, “reducing tobacco use” could serve, to some extent, as a proxy for harm reduction.
Today, however, there are distinct differences in the risk levels associated with various products.
Douglas emphasized that the real focus today should not merely be on whether an individual uses a product legally defined as “tobacco,” but rather on:
- “Exactly what product they are using, and where that product falls on the risk continuum.”
Citing U.S. data from 2024, he noted that among adults aged 18 to 24, the prevalence of cigarette smoking was 3.4%, while vape use stood at 14.8%. These figures are corroborated by an analysis of the 2024 National Health Interview Survey published by the National Center for Health Statistics. Douglas did not characterize vapes as “harmless,” nor did he view their use by non-smokers as ideal.
He cited this data to support his assessment that the nicotine market is undergoing structural change, and that combustion may not necessarily remain the primary method of nicotine intake for future generations.
Douglas Urges Risk-Based Regulation of Tobacco Products
In his view, the “continuum of risk” should not merely be a concept describing risk differences between products, but should also serve as a key principle for policy design.
Douglas proposed that regulatory, tax, and pricing policies should reflect the differences in risk between products, while also incorporating strict product standards and measures to protect minors.
He placed particular emphasis on the clarity and predictability of the regulatory pathway.
Douglas argued that companies developing lower-risk products should clearly understand the scientific evidence required by regulators; furthermore, if a company meets the relevant standards, it should be able to reasonably expect a timely regulatory decision.
Regarding enforcement, he suggested that a distinction must be made between the legal, regulated market and the illicit market.
On the subject of risk communication, he advocated for providing adult smokers with more accurate information regarding relative risk.
He also emphasized that regulatory systems must continuously adapt as scientific evidence, products, and markets evolve.
Douglas Focuses on Potential FDA Adjustments to the PMTA Review Process
Douglas also linked the aforementioned policy framework to a recent regulatory development that emerged just days before the summit.
He noted a Wall Street Journal report from September 23 stating that the U.S. Food and Drug Administration (FDA) is expected to revisit its 2021 final rule regarding Premarket Tobacco Product Applications (PMTA) in order to improve the efficiency of the review process for market authorizations of products such as vapes and nicotine pouches.
The PMTA process is a critical regulatory review step that new tobacco products in the U.S. must undergo before entering the legal market.
For products like vapes and nicotine pouches, companies are required to submit scientific evidence to the FDA via the PMTA process, allowing the agency to evaluate whether the products meet the marketing standards mandated by U.S. law.
This regulatory development occurred on September 24. According to publicly available information at the time, potential adjustments might include streamlining certain scientific research requirements, shortening review times, and offering greater flexibility in the review of applications for non-combustible nicotine products.
It is important to note that, as of September 25, the FDA had not yet formally announced the implementation of these rule changes.
The APPH Standard Remains Central to FDA Review
Meanwhile, the “Appropriate for the Protection of the Public Health” (APPH) standard under U.S. law remains unchanged.
APPH is the core statutory standard the FDA uses when reviewing new tobacco products for market authorization. Simply put, the FDA does not merely assess the risk a product poses to an individual user; rather, it must evaluate the potential impact the product’s market entry could have on public health across the general population.
Regarding the potential adjustments reported by The Wall Street Journal, Douglas remarked:
- “The key lies in the specific details.”
However, he also noted that if these changes ultimately establish a more efficient and predictable regulatory pathway for “lower-risk products backed by scientific evidence,” it would represent a:
- “Welcome correction.”
This assessment is also grounded in the current policy landscape.
In recent years, the FDA has begun efforts to improve the efficiency of Premarket Tobacco Product Application (PMTA) reviews. In 2025, the agency launched a pilot program for reviewing PMTAs for nicotine pouches, which included enhanced direct communication between regulators and applicant companies.
Subsequently, the FDA stated that this mechanism helped it complete the scientific review of six “on! PLUS” nicotine pouch products at a record pace and that it would evaluate whether some of these practices could be applied to the broader PMTA review system. Further details can be found in the FDA’s official announcement regarding the authorization of the six “on! PLUS” nicotine pouch products.
Why Market Authorization Alone May Not Be Enough
- “Market authorization alone does not equate to a public health strategy.”
However, Douglas believes that even if the FDA improves the efficiency of product authorizations, public health goals cannot be achieved by relying solely on “authorization” itself. He stated:
- “Market authorization alone does not equate to a public health strategy.”
Douglas argues that even if a lower-risk product receives regulatory authorization, its potential public health value remains limited if adult smokers are unaware of the product, do not understand its relative risks, distrust it, cannot distinguish it from illicit products, or do not consider it a viable substitute for cigarettes.
He also cited FDA research indicating that only about one-fifth of adult smokers believe vapes contain fewer harmful chemicals than cigarettes.
The FDA has previously highlighted this finding in public materials regarding perceptions of the relative risks of tobacco products.
The FDA also emphasizes that no tobacco product is safe; however, existing scientific evidence indicates a continuum of risk among different tobacco products, with combustible cigarettes at the highest-risk end of the spectrum.
In Douglas’s view, this implies that risk communication is an integral part of the regulatory system, rather than an ancillary issue outside of regulation.
He noted that such communication should not be the sole responsibility of the FDA but should also involve healthcare professionals, consumer organizations, and the media to help adult smokers make choices based on more accurate information.
Protecting Minors and Harm Reduction Are Not Inherently Conflicting Goals
Douglas further argues that protecting minors and tobacco harm reduction (THR) should not be viewed as inherently conflicting objectives.
He compared data on vape use among U.S. youth from 2019 and 2025.
In 2019, the prevalence of current vape use among U.S. high school students reached 27.5%. This figure comes from an analysis of the 2019 National Youth Tobacco Survey published by the Centers for Disease Control and Prevention (CDC).
By 2025, the rate of current vape use among U.S. high school students had dropped to 7.1%, with an overall rate of 5.2% across middle and high school students. During the same period, the rate of current cigarette use among all surveyed students was 1.4%. These figures are based on results from the 2025 National Youth Tobacco Survey released by the FDA.
Douglas cites this shift as evidence supporting his position.
He maintains that protecting young people and advancing harm reduction are “not mutually exclusive goals.” He said:
- “We can achieve both simultaneously.”
It should be noted that these data reflect changes in usage patterns across the general population over different years; they do not, in isolation, prove a direct transition from combustible cigarettes to vapes at the individual level.
Douglas used this data primarily to illustrate that protecting minors and implementing harm-reduction policies are not mutually exclusive choices.
Building a Broader Public Health Ecosystem
The “public health ecosystem” Douglas proposed extends far beyond mere product authorization.
The components he outlined include: prevention, smoking cessation support, clinical care, surveillance, product standards, regulatory predictability, enforcement, accurate communication regarding relative risks, responsible innovation, and accountability mechanisms for corporate non-compliance.
He believes that these factors must work in concert to foster a lower-risk environment, creating the conditions for the product to compete effectively against combustible cigarettes.
Finding Common Ground Amid a Polarized Tobacco Policy Debate
Douglas also addressed the long-standing issue of extreme polarization in the field of tobacco policy.
He noted that disagreements between opposing sides often devolve into accusations regarding “malicious intent,” moral issues, or even personal motives, none of which helps public health policy effectively solve the problem at hand.
He stated:
- “We should be able to disagree vehemently while still finding substantial common ground.”
This perspective echoed the overarching theme of the summit session.
The session also honored the late tobacco policy expert Scott Ballin and emphasized the importance of restoring dialogue and consensus-building around public health issues characterized by long-standing division.
However, for Douglas, the ultimate test of a system’s effectiveness hinges on a more specific question:
Rather than simply asking, “Should a particular product be allowed on the market?” one should ask:
- “What kind of public health and regulatory system can most rapidly reduce the disease and death caused by smoking?”
Douglas described the ultimate goal as establishing an ecosystem:
“…in which combustible cigarettes gradually lose their place.”
He believes that regulatory leadership can help build such a system and accelerate society’s transition from combustible products to alternative options.
