Summary

This year’s conference format includes interactive dialogues throughout the day between a broad spectrum of stakeholders about how to most effectively regulate the broad spectrum of tobacco products, both in the U.S. and on a more global basis. Discussions will also include perspectives amongst stakeholders as to what a comprehensive tobacco and nicotine policy based on the continuum of risk should look like, and whether the divide between stakeholders is becoming wider.

Register

Coming soon.

Last Year’s Agenda

9:00 AM
Registration and Continental Breakfast

9:00–9:05 AM
FDLI Welcom

9:05–9:45 AM
Keynote Address: FDA’s Regulation of Tobacco: A Year in Review

In this keynote address, FDA’s Director of the Center for Tobacco Products, will offer his perspective on the policy behind deeming, the critical changes it would have on industry, and the impact it is likely to have on public health.

9:45–10:00 AM
Networking Break

10:00–10:05 AM
Panel Discussions: Setting the Stage          

10:05–11:00 AM
Regulatory Framework

What would or should a comprehensive regulatory framework, for dealing with a rapidly changing tobacco and nicotine marketplace, look like? What are the barriers to designing and implementing such a framework not only in the US but in Europe and globally as well? What are the essential elements that need to be considered to make such a framework more responsive to public health needs of the future? Should all tobacco, nicotine and possible newer products be brought under a single (or coordinated) regulatory umbrella and products regulated based on their risks and relative risk?

11:00–12:00 PM
FDA’s Deeming Regulations v. Other Approaches to the Regulations of ENDS such as in the UK

Do the FDA’s ‘Deeming’ regulations benefit or hinder public health? What components of them will have the greatest impact on public health? What components are barriers to advancing public health? What might be the outcome of the legal challenges to them? What do such uncertainties mean to public health and consumers, as well as to manufacturers? Are other approaches, such as those being considered in the UK, a more viable alternative?

12:00–1:15 PM
Luncheon with Guest Speaker

1:15–1:30 PM
Break

1:30–2:15 PM
Product Standards v. The Current PMTA/MRTP Processes and Pathways

What are FDA’s current requirements to bring a premarket tobacco product application (PMTA) and modified risk tobacco product (MRTP) to market and how have they been applied by CTP? Do these requirements advance or hinder public health objectives? Could product standards be a more efficient way to proceed? What are the effects (costs, barriers to entry, stifling of innovation, scope of paperwork and studies needed, etc.) of such approaches on those wishing to market PMTA/MRTPs?

2:15–3:00 PM
Nicotine: Rethinking and Evaluating the Role of Nicotine – Public Health Benefit, Pathway to Addiction or Both?

There is a growing debate and discussion about how ‘society’ should deal with ‘nicotine’. What are the effects of various delivery forms of nicotine on the public health. Can such effects be minimized? Should the use and availability of so-called ‘cleaner nicotine’ products be actively supported especially for use as an alternative to smoking? What are the guiding regulatory principles to consider?

3:00–3:30 PM
Networking Break

3:30–4:15 PM
Preventing Initiation and Use of Tobacco and Nicotine Products by Children and Adolescents

What more can or should be done? Where do the problems, challenges and opportunities lie? What are the collective roles of FDA (and other agencies), NGO’s, manufacturers, distributors, retailers and others? Can there be better collaboration and cooperation?

4:15–5:00 PM
Improving Scientific Research Collaboration and Transparency to Improve Regulatory Outcomes

This discussion will include such topics as what to do with potential ‘bias’ in how studies are designed, conducted, and reported and how can researchers, including those in industry, better engage and share scientific efforts. What is the appropriate role of the FDA or other governmental institutions and should consideration be given to the establishment of an independent third party such as a scientific consortium? Can organizations such as Society for Research on Nicotine and Tobacco (SRNT) and Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) play more active roles?

Speaker Biographies

Coming soon.

Onsite Materials

Coming soon.

Continuing Legal Education

Continuing Legal Education credits will be awarded for attending this program.

FDLI applies directly to Ohio, Pennsylvania, and Virginia. New York recognizes Pennsylvania approvals. These states are generally recognized as approved jurisdictions by other states, however, each state bar has its own requirements, and it is the responsibility of the attorney seeking CLEs to know and fulfill such requirements.  Please contact your Bar Association for guidance.

Virginia, Pennsylvania, and Ohio approvals are pending.

FDLI applies for CLE credits prior to each meeting but sometimes the approval is not granted until after the meeting. As approvals are received, updated CLE information will be posted here, and you can request to be notified.

Location and Overnight Accommodations

Coming soon.