At this year’s Food and Drug Law Institute (FDLI) Tobacco and Nicotine Conference, Acting Director for the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), Dr. Bret Koplow, delivered a defining keynote — not marking a first, but rather a culmination of the FDA’s evolving stance on tobacco harm reduction (THR).
The address built on a decade of regulatory milestones showing the FDA’s deepening commitment to evidence-based evaluation of less harmful nicotine alternatives. This represents an evolution from cautious acknowledgment to active integration of harm reduction as a principle within the agency’s public health mission.
A Decade of Regulatory Evolution
The FDA’s recognition of tobacco harm reduction has developed progressively, grounded in the scientific understanding that combustion — not nicotine — is the primary cause of smoking-related disease.
- Continuum of Risk (2012–Present):
The FDA has long acknowledged that tobacco products exist along a continuum of risk. Combusted cigarettes pose the greatest danger, while smoke-free alternatives such as nicotine pouches, heated tobacco, and e-cigarettes offer substantially lower exposure to toxicants for adult smokers who continue to use nicotine. - 2015 – Swedish Match Snus Authorization:
In a landmark decision, the FDA authorized the sale of Swedish Match snus products containing significantly lower levels of tobacco-specific nitrosamines (TSNAs), explicitly acknowledging that reducing exposure to carcinogens could reduce cancer risk, one of the earliest formal nods to THR in regulatory practice. - 2020 – Heated Tobacco Product (IQOS) MRTP Authorization:
The FDA authorized Philip Morris International’s IQOS as a Modified Risk Tobacco Product with reduced exposure claims. This represented a major policy step, validating that regulated smoke-free products could deliver measurable public health benefits. - 2025 – Nicotine Pouches (ZYN) Authorization:
In January 2025, the FDA approved Swedish Match’s nicotine pouch products (ZYN) for U.S. sale, concluding they contain substantially lower levels of harmful ingredients than cigarettes or smokeless tobacco. The FDA also recognized evidence showing these products help adult smokers switch without driving youth uptake.
Together, these milestones demonstrate a clear and evolving pattern of harm reduction acknowledgment, guided by scientific evidence and a consistent focus on protecting public health through proportionate regulation.
Reframing Public Health at FDLI 2025
Dr. Koplow’s keynote reinforced and advanced this trajectory. His message was clear: harm reduction is not an alternative to tobacco control, it is the logical outcome of effective tobacco regulation.
Key Messages from the FDA Address
- Harm Reduction as a Public Health Principle
Harm reduction was presented as a natural extension of the FDA’s public health standard, a recognition that scientifically substantiated alternatives like nicotine pouches, e-cigarettes, heated tobacco, and snus can support population-level health gains by replacing cigarettes. - Comparative Risk Communication
The FDA is committed to improving public understanding of relative risk across nicotine products, including correcting misinformation that continues to conflate nicotine with smoking-related disease. - Evidence-Based Switching, Not Just Cessation
While complete cessation remains ideal, Dr. Koplow emphasized that switching completely away from combustible products is a valid and measurable harm-reduction outcome. - Non-Negotiable Youth Protection
Harm reduction is for adults. The FDA will continue enforcing youth access restrictions, including flavour limitations, while exploring new technologies such as age-gating to maintain adult access without youth exposure. - Regulatory Modernisation
The FDA has now reviewed more than 26 million PMTAs, cutting its backlog by 60%. The newly launched Nicotine Pouch Pilot Program aims to streamline evaluations for oral nicotine products, creating a model for other reduced-risk categories.
Why It Matters
This evolution reflects a turning point in regulatory philosophy, a shift from simply controlling tobacco to proactively reducing the harm associated with its use.
For the first time, the FDA’s leadership articulated harm reduction not as a controversial compromise, but as a scientifically grounded, public-health–aligned strategy.
The result is a framework that encourages innovation, regulatory clarity, and risk-proportionate policy, essential for driving down smoking-related morbidity and mortality.
GINN’s Perspective
GINN welcomes the FDA’s evolving stance as a long-overdue affirmation of science-based harm reduction within U.S. public health policy.
By embedding the continuum of risk into its regulatory logic, the FDA is not only aligning with global evidence, including Sweden’s success in achieving smoke-free status but also reaffirming that adult access to safer alternatives is integral to ending smoking.
This continued evolution shows that responsible innovation, when guided by science and ethics, can transform nicotine regulation from prohibition to pragmatic prevention, a foundation for saving lives worldwide.
Sources
- U.S. Food and Drug Law Institute (FDLI) Tobacco & Nicotine Conference, October 2025.
- U.S. FDA, “The Continuum of Risk and Public Health Standard,” CTP, 2023.
- U.S. FDA, “FDA Authorizes Sale of Swedish Match Snus Products,” Press Release, 2015.
- U.S. FDA, “FDA Authorizes IQOS Tobacco Heating System as a Modified Risk Tobacco Product,” Press Release, July 2020.
- U.S. FDA, “FDA Authorizes Marketing of ZYN Nicotine Pouches,” January 2025.
- Chris Allen, LinkedIn commentary (Broughton Group).
