Agenda coming soon

‍OWNiT: Entrepreneurship in Nicotine and Tobacco

Networking Coffee Break

Tobacco Science Showcase: Opening Remarks

Presenters talk about the interplay between the tech and the retail processes needed to implement a more sophisticated, tech & data driven YAP, and how that could impact future survey and study results.

Tobacco Science Showcase: Science

Tobacco Science Showcase: Real World/Process

Tobacco Science Showcase: Technology

Tobacco Science Showcase: Discussion

Welcome Networking Reception & Dinner

sponsored by Troutman Pepper Locke

Dessert Drinks & Networking

sponsored by Black Buffalo and OWNiT

Breakfast

sponsored by PinneyAssociates

Welcome

Panel: A New Regulatory Landscape

With a new administration in place, the regulatory landscape for tobacco and nicotine products is shifting. This panel will explore the potential impact of leadership changes at HHS and the FDA, as well as what is being seen from the new administration in terms of regulatory activity. Experts will analyze what these changes could mean for product authorizations, enforcement actions and harm reduction policies.

Networking Coffee Break

‍Panel: Regulatory Pathway Solutions

As the regulatory landscape evolves, questions remain about the efficacy, transparency, and speed of product application reviews. This panel will explore the current status of application reviews, the FDA’s efforts to prioritize submissions, and how recent litigation may be shaping its review philosophy. Panelists will also discuss the agency’s evolving interpretation of “Appropriate for the Protection of Public Health” (APPH) and propose strategies to enhance the regulatory process for smoke-free products.

Networking Coffee Break

‍Panel: Solutions Based in Science: Smoke-Free Product Standards

Baseline product standards, which could take the form of voluntary consensus standards, could streamline the pathway to market for potentially reduced risk products for adults who smoke. FDA uses product standards in its regulation of pharmaceuticals and food, but they have not yet been established for regulating e-cigarettes and other non-combustible nicotine products. Could the establishment of product standards based upon the available scientific, clinical, and public health research provide regulatory and scientific clarity, and ultimately a wide variety of authorized products? Panelists will discuss how product standards might be developed in this space, and the pros and cons of such an approach.

Lunch

sponsored by Tobacco Technology

Keynote: Zyn TPL Overview

Keynote

‍Panel: Correcting Consumer & Health Care Provider Misperceptions

Adult tobacco consumer misperceptions regarding the role of nicotine and relative risk of tobacco products is a barrier to switching to smoke-free products. These misperceptions are also held by health care providers, the very people adult tobacco consumers trust for health information. Hear from the FDA, manufacturers, and academics about the barriers and opportunities to provide truthful and accurate information so adult tobacco consumers can make informed decisions based on science and evidence – not misinformation. How can we meaningfully move consumer and health care provider understanding forward without inadvertently promoting use of smoke-free products to unintended audiences (i.e. nonusers and youth)? What role does MRTP play? What research is being done / informing us in these efforts? What more can FDA do today to inform health care providers, while it waits for messaging research to be completed?

Networking Coffee Break

‍Panel: Exploring Recent FDA Memoranda

In an effort to enhance transparency, FDA released a series of regulatory science policy memoranda outlining its latest thinking on toxicology assessments, excess lifetime cancer risk (ELCR) calculations, and other critical scientific evaluations in tobacco product applications. These memos provide valuable insights into the FDA’s evolving approach to reviewing PMTAs, shaping testing methodologies, and setting new regulatory expectations. Hear experts discuss these memos, exploring their impact on risk assessments, study design, and the overall PMTA process.

Closing & Special Programing

Networking Reception & Dinner

sponsored by Sapphire Sciences

Breakfast

sponsored by Smoker Friendly

Panel: The Legislative Landscape: State and Local Tobacco Policy Update

As state and local governments continue to shape the future of tobacco policy, industry stakeholders must stay ahead of rapidly evolving policies. This panel will provide a comprehensive update on key legislative and regulatory developments across the U.S., including proposed tax measures, flavor and product bans, and state directory bills. Experts will examine the impact and challenges of these policies on the industry and market as well as the emerging trends in enforcement and litigation.

Welcome

Networking Coffee Break

‍Panel: Being Compliant in an Illicit Market – What's the Way Forward?

The accelerating growth in unlawful and unregulated e-vapor and nicotine pouch products as well as emerging nicotine analogues is a significant problem that threatens the long-term success of federal tobacco regulation. This panel would include perspectives from stakeholders in the supply chain, including manufacturers, wholesalers, retailers, and consumers sharing their experiences in trying to comply with FDA regulations while competing against the huge illicit market in e-vapor products; and share learnings about other growing illicit markets, including pouches and nicotine analogues, and offer solutions at the federal and state levels.

Networking Coffee Break

‍Panel: Post-Market Surveillance: Balancing Innovation While Guarding Against Unintended Consequences

This panel would discuss the role PMTA post-market authorization surveillance could play in helping get more FDA authorized smoke-free products to market while protecting against concerns about youth and non-users. Panelists could provide their perspectives on the best approach to improve public health, including the pros and cons of FDA implementing the precautionary principle vs. relying on post-market surveillance in making PMTA decisions.

Lunch Sponsored by Sanova

‍Panel: Incentivizing Investment in the "Ideal" Market

In the "ideal" nicotine and tobacco products market, all adult consumers would understand the relative risk of tobacco products, have access to a portfolio of regulated smoke-free products, and be provided with cessation counseling and support. And youth access and usage would be minimal to non-existent. Achieving this vision requires capital investment across all stages — from venture capital funding disruptive innovations to institutional investments in mature corporations – driving the transition toward a harm reduction market. This panel will bring together investors to discuss all these vantage points, whether investors are currently incentivized to put capital to work in the "ideal" state, and what investors are looking for to make investments into the "ideal" state.

Networking Coffee Break

‍Panel: Different Seats, Same Table: Finding Common Ground & Solutions for Adults Who Smoke

Hear from academic research and health advocacy communities how the changing nicotine environment has influenced their policy positions. Have they encountered situations where their objectives seemed to align at least in part with those of the tobacco and nicotine industry? What can both industry and public health do to better foster engagement? What can all stakeholders do to assist the agency?

Closing Remarks