Key Points
● From “End Game” to “End State”: Zeller argued that tobacco harm reduction should begin by defining the desired “end state,” then work backward to determine regulatory priorities, product roles and future actions.
● Two Possible Future States: One would remove combustible tobacco products while retaining alternative tobacco and nicotine consumer products; the other would also remove consumer nicotine products, leaving nicotine only for therapeutic use.
● Dual Use Remains a Key Question: Zeller said the greatest risk reduction comes from complete substitution for cigarettes, while the long-term significance of dual use remains unresolved.
● Risk Reduction Requires Better Metrics: He said cigarettes smoked per day alone may not adequately measure reduced risk, pointing instead to biomarkers of exposure as a potentially more meaningful indicator.
● Nicotine Misperceptions Remain a Barrier: Zeller said nicotine does not directly cause cancer, lung disease or heart disease, while emphasizing continued concerns around addiction and youth use.
2Firsts
New York, September 25, 2026
The 2026 New Approaches Summit was held Friday at the Harvard Club of New York City under the theme “Saving Lives in the 21st Century.” The meeting brings together participants from public health, regulation, science and industry to discuss tobacco control and harm reduction. 2Firsts is reporting from the event.
Mitch Zeller, J.D., former director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), called for a reframing of the long-running debate over tobacco harm reduction.
Zeller served as CTP director from March 2013 through April 2022, leading the center for more than nine years. In 2017, Zeller and then-FDA Commissioner Scott Gottlieb set out a nicotine-focused regulatory framework that placed nicotine and addiction at the center of FDA tobacco policy. The approach included consideration of reducing nicotine in combustible cigarettes to minimally or non-addictive levels, while recognizing differences in risk across nicotine-delivery products and seeking to address public misperceptions about nicotine.
At the summit, Zeller argued that the discussion should move beyond the familiar concept of a tobacco “end game” and instead focus on the desired “end state.”
He described two possible future states. In one, combustible tobacco products would be removed from the market, while alternative tobacco and nicotine consumer products would remain available. In the other, consumer nicotine products would also be removed, leaving nicotine available only for therapeutic use.
Zeller proposed starting with that fundamental choice and then working backward. Participants, he said, should first identify the future state they want, then consider what role alternative and less harmful products would play, what gaps remain, and what would need to happen over the next five to 10 years to reach that outcome.
The approach, he suggested, could move the discussion away from beginning with entrenched arguments over harm reduction or individual product categories.
Dual Use Remains an Unresolved Question
Zeller also devoted significant attention to dual use — the simultaneous use of cigarettes and alternative nicotine products.
He said the greatest reduction in risk from alternative products comes through complete substitution for cigarettes, while noting that important questions remain about what dual use means in the real world.
One possibility, he said, is that dual use represents a transitional period before smokers eventually switch completely. Another is that it becomes a persistent pattern in which consumers continue smoking cigarettes while also using alternative products.
During the discussion following his remarks, Zeller said the number of cigarettes smoked per day should not, on its own, be treated as an adequate measure of risk reduction.
Instead, he pointed to biomarkers of exposure as a potentially more useful measure of whether reducing cigarette consumption actually results in lower exposure to harmful constituents.
“The ultimate goal obviously should be becoming cigarette-free,” Zeller said, while adding that meaningful reductions in toxicant exposure could still matter for smokers who are unable to switch completely.
Nicotine Misperceptions Remain a Barrier
Zeller also returned to an issue that was central to the FDA’s nicotine-focused framework during his tenure: public understanding of nicotine.
He said nicotine does not directly cause cancer, lung disease or heart disease, while emphasizing that it remains addictive and that uptake among people who do not currently use tobacco products, particularly young people, remains a concern.
In his closing remarks, Zeller said nicotine risk misperceptions need to be addressed and called for more authorized products to be available on the market.
“We need more authorized products on the marketplace,” he said, adding that the field also needs “more answers and fewer questions.”
Follow 2Firsts for the latest coverage from the 2026 New Approaches Summit.
Mitch Zeller speaks at the 2026 New Approaches Summit in New York. Photo: 2Firsts
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