TMA's 103rd Annual Meeting & Conference
April 9-11, 2018
Lansdowne Resort — Leesburg, VA
This year’s TMA Annual Meeting and Conference looks at the puzzle of FDA’s new policy direction following FDA Commissioner Scott Gottlieb’s July 2017 speech. What we’ve heard from our Members is that many stakeholders are grappling with what this new policy direction means.
Commissioner Gottlieb outlined a number of policy goals for CTP; those are the puzzle pieces. TMA’s 103rd Annual Meeting will try and help you fit them together… to complete the puzzle. We start with four basic pieces: A Nicotine Product Standard, the Cigar Exemption, FDA Premarket Submissions and Harm Reduction. Each subject is a different piece of the puzzle but taken together encompasses the entire tobacco and nicotine universe.
There’s a lot new this year aside from FDA’s policy shift. The conference is earlier and at a new location. And we’re changing format: April 9 will be a welcome reception and networking opportunity. The conference itself will be full days on April 10-11. Over these two days, we will dive deeply into the complexities of our four large puzzle pieces.
Confirmed Keynote Speaker: Mitch Zeller, Director of FDA’s CTP
Opening Keynote: The TMA Board of Directors is grateful to FDA-CTP Director Mitch Zeller who graciously agreed to be our opening keynote and will be kicking off the first full day of activities on April 10th. Mitch has spoken at every TMA since joining CTP and TMA thanks Mitch for his appearance this year and his commitment speaking at TMA’s Annual Meetings & Conferences for 5 years now.
Nicotine Product Standards: An exploration of the issues associated with FDA's aim to reduce nicotine in combustible cigarettes. As FDA and stakeholders consider this ambitious policy objective, our conference will start with looking at examples of nicotine reduction policies and then exploring what “reduction” means in practical terms, what’s its impact on society and individual smokers? Will it work and what policy architecture needs to be drawn up?
Cigar Exemption: FDA is going to look back at its decision to not embrace policy option #2 in the draft deeming regulation. Is that it – should FDA be looking deeper into this? What’s exempted and what’s going to be the debate on this for and against? What’s the evidence and how can attendees work with it?
Clarity of Vision: Constructing a Better Product Authorization System: A comprehensive review and call to action on assisting the agency with constructing a better system to get all products evaluated for market fitness. Hear from consultants on what the key trends and issues are for current submissions and how that relates to what your organization is doing. Understand the work organizations and groups are doing to advance various process components. Pivot toward FDA’s eventual “ask” on what makes a better submission.
Harm Reduction: What is the policy environment necessary to have a conversation about harm reduction between industry and civil society and between all stakeholders and consumers? Why don’t we have it and what can or are we doing to effect that? Understand what shifting to harm reduction means for regulators, business (manufacturers, wholesalers, retailers, and farmers) and what’s being done around this work that is making progress.