The 2025 Food and Drug Law Institute (FDLI) Tobacco and Nicotine Conference delivered something the industry has been waiting for: a visible and vocal presence from the FDA’s Center for Tobacco Products (CTP), and most significantly, an explicit endorsement of tobacco harm reduction as a core part of its regulatory philosophy.
Throughout the two-day event, attended by stakeholders from public health, government, industry, and advocacy groups, one theme stood out: change is happening. The combination of CTP leadership participation, regulatory clarity, and open dialogue indicated a new, more pragmatic chapter in nicotine policy may be unfolding.
FDA Puts Harm Reduction on the Record
A pivotal moment came during the keynote address from Bret Koplow, Acting Director of CTP. For the first time in a public setting, the FDA clearly and directly acknowledged harm reduction as a legitimate principle within its regulatory framework.
Koplow described harm reduction as a natural outcome of applying the “Appropriate for the Protection of Public Health” (APPH) standard outlined in the Tobacco Control Act. Rather than focusing solely on cessation, FDA now recognises that authorised reduced-risk products, such as nicotine pouches, heated tobacco, e-cigarettes, and snus, can play a meaningful role in reducing smoking-related harm.
Key highlights from his remarks included:
This reframing of regulatory intent marks a philosophical evolution for CTP, one that could pave the way for more accessible and evidence-based product pathways.
Panels Reflect a Growing Appetite for Transparency and Efficiency
The conference was rich with insight from FDA leaders and tobacco control experts on how CTP’s processes are evolving to become more science-driven and collaborative.
During a panel moderated by Stacy Ehrlich, Cristi Stark from CTP’s Office of Science offered detailed insight into the new nicotine pouch pilot program. Stark explained that the pilot encourages early and open dialogue between the FDA and manufacturers, rather than prolonged silence followed by deficiency letters. Key areas of focus include product consistency, abuse liability, adverse experience reporting, and characterisation.
In a particularly useful clarification for industry, she confirmed that changes to child-resistant packaging using the same materials would not require a new STN, though updated stability data would be expected.
Panellists Matt Holman, Sarah Marking, and Brian Miller echoed the sentiment that CTP is adopting a more collaborative and responsive tone, drawing comparisons to other FDA Centres that have embraced clearer, more interactive pathways for regulated industries.
Enforcement, Unauthorised Products, and the Road Ahead
Another important topic tackled during the event was how to manage the persistent presence of unauthorised tobacco products on the market.
In a panel moderated by Lillian Ortega, John Verbeten from CTP reiterated the agency’s position: all new tobacco products must receive FDA authorisation before they can legally be sold. The widespread “submit and sell” approach used by some manufacturers was firmly rejected as illegal.
Brian King, now outside of CTP but still influential in the policy space, raised concerns around nicotine analogues, noting that regulation is a matter of “when, not if.” The panel highlighted the need for coordinated efforts across the supply chain, from manufacturers to retailers to enforcement bodies, to ensure a compliant marketplace.
These statements reiterate FDA’s clear stance that there are currently only three pathways to legally market a nicotine-containing product.
A More Open FDA?
From the opening keynote to the final panel, there was a noticeable shift in tone from CTP, less defensive, more engaged, and more transparent. Speakers like Beth Oliva described FDLI as a “neutral ground” for open discussion, and the active involvement of FDA staff supported that view.
Across the sessions, from policy frameworks to scientific standards and enforcement, there was a shared recognition of the importance of harm reduction, consumer education, and regulatory clarity.
While challenges remain, particularly in navigating unauthorised products and ensuring youth protection, the FDA’s visible and vocal presence at FDLI 2025 is a strong signal that it may finally be ready to lead with clarity and confidence.
Closing Thoughts
For industry stakeholders, public health experts, and adult nicotine consumers alike, this year’s FDLI conference felt like more than just a regulatory update; it felt like a moment of transition.
Whether the agency fully follows through on this reframed vision remains to be seen. But for now, there is reason for cautious optimism that the FDA is ready to embrace a more balanced, science-led approach to nicotine regulation.
For more information on how Broughton can support with bringing your reduced-risk nicotine products to market, please get in touch.