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Join a diverse number of stakeholders—public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others—for this two-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the U.S. and globally. Hear from FDA’s Center for Tobacco Products Director, Mitch Zeller, to learn about the latest updates on regulations, guidance documents, and other initiatives. The conference will also include a number of timely tobacco and nicotine issues that will allow for interactive dialogues between the panelists and audience.

Highlighted Topics:

  • FDA’s Center for Tobacco Products: Key Updates
  • Navigating Product Pathways and Elements of Uncertainty in Regulatory Decision Making
  • Misperceptions around Nicotine and Accurately Communicating Risk Information
  • Identifying and Interpreting Relevant Science
  • Youth Use of E-Cigarettes
  • Nicotine Steering Committee Update: What is the Current Status of Over-the-Counter Nicotine?
  • The Status of Product Standards
  • Impact of Illicit Trade of Tobacco and Nicotine Products

2018 Planning Committee: 

David Abrams, New York University
Scott Ballin, Independent Consultant
Donald Becker, Turning Point Brands, Inc.
Dean R. Cirotta, EAS Consulting Group, LLC
Azim Chowdhury, Keller and Heckman LLP
Marc Firestone, Philip Morris International
Carole Folmar, ITG Brands
Robyn Gougelet, Pinney Associates, Inc.
Bryan M. Haynes, Troutman Sanders LLP
Dennis Henigan, Campaign for Tobacco-Free Kids
Kathleen Hoke, University of Maryland Law School
Eshael Johnson, FDA – CTP
Jose Luis Murillo, Altria Client Services LLC
Ray Niaura, New York University
Elizabeth Oestreich, Greenleaf Health, Inc.
Valerie Solomon, RAI Services Company
Donna Vallone, Truth Initiative

Register by August 23 and SAVE

Industry & Firms

$1,299
  • +$500 for non-members
  • +$100 after 8/23/2018
  • +$100 after 9/20/2018

Non-Profit

$799
  • +$100 for non-members
  • +$100 after 8/23/2018
  • +$100 after 9/20/2018

Government

$799
  • +$100 for non-members
  • +$100 after 8/23/2018
  • +$100 after 9/20/2018

Academic

$799
  • +$100 for non-members
  • +$100 after 8/23/2018
  • +$100 after 9/20/2018

Student

$99
  • student registration
  • full-time students only
  • transcripts required
Register Now


Are You New to Tobacco Products?

Add the one-day training course, Introduction to Tobacco Law and Regulation, to your conference registration to gain a comprehensive overview of the laws and regulations affecting the tobacco products industries and save $100 off the combined fees.

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

Silver Sponsor

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Agenda

subject to change

Thursday, October 25

8:15 – 8:55 AM
Registration and Continental Breakfast

8:55–9:00 AM
FDLI Welcome and Opening Remarks
Amy Comstock Rick
, President & CEO, Food and Drug Law Institute

9:00–9:45 AM
Keynote Address
Mitchell R. Zeller
, Director, Center for Tobacco Products (CTP), Office of Medical Products and Tobacco, FDA

9:45–10:45 AM
Reactor Panel
Panelists will respond to Director Zeller’s comments regarding effective dialogue among stakeholders, updates on the Advanced Notice of Proposed Rulemakings, and other current policy initiatives.

10:45–11:15 AM
Networking and Coffee Break

11:15 AM–12:15 PM
The Latest on Product Standards and Other Potential Regulatory Action
In March 2018, FDA released three Advanced Notices of Proposed Rule Making (ANPRM) seeking comments on a potential product standard for nicotine levels in cigarette products, the role of flavors in tobacco products, and the regulation of premium cigar products.  In this session, panelists will discuss those ANPRMs and the next set of issues on which FDA has said it will focus, including product pathways, Tobacco Product Manufacturing Practices, and product standards for batteries and liquids in e-vapor products.

12:15–1:15 PM
Networking Lunch

1:15–2:15 PM
Review of Nicotine Products as Cessation Aids
How do we improve the chances that current approved nicotine products will help users quit combustible cigarettes? What are the concerns surrounding the toxicology of e-cigarettes and e-vapor products? How do we set standards to ensure further innovation in tobacco products that have the potential to be medical products? What is the potential OTC process for therapeutic nicotine products?

2:15–3:15 PM
Element of Uncertainty When Making Business and Regulatory Decisions
Panelists will address making agency and business decisions in a complex regulatory environment while weighing agency flexibility to adapt to changing circumstances. This will include discussion of navigating the complexities of the premarket review process.

3:15–3:45 PM
Networking and Coffee Break

3:45–5:00 PM
Protecting Youth: Targeting Appropriate E-Cigarette Users
In this session, panelists will assess the balance between youth e-cigarette risks and adult cessation product benefits. What product advertising challenges are associated with reaching the target audience? How has FDA responded to the emergence of underage use of popular nicotine products? What are the responsibilities of industry? This panel will also address FDA’s misbranding authority and FTC’s deceptive trade practice authority related to future enforcement by FDA against flavored tobacco products.

5:00–6:30 PM  
Networking Reception

Friday, October 26

8:15–8:55 AM
Registration and Continental Breakfast

8:55 – 9:00 AM
FDLI Welcome and Announcements

9:00–10:00 AM 
Risk Communications Part 1: Presentations by Public Health Experts
In July 2017, the FDA announced a comprehensive approach to regulating tobacco and nicotine products that placed nicotine as the keystone of their efforts. Commissioner Gottlieb has listed the need to correct the public’s misperceptions of nicotine as an integral part of this comprehensive plan. The American Cancer Society has indicated they will engage the public to correct nicotine misperceptions. In this session, panelists will discuss how to correct misrepresentations surrounding nicotine, organizations who can serve as communicators, and ways to use targeted messaging to educate the public. 

10:00–10:45 AM 
Risk Communications Part 2: Questions and Discussion by Expert Practitioners
Following the presentation portion, a panel of expert practitioners will consider the array of opportunities and barriers to success for overcoming risk communication challenges.

10:45–11:00 AM
Networking and Coffee Break

11:00 AM–12:00 PM 
How to Identify and Interpret Quality Science
Scientific studies form the basis of many tobacco and nicotine laws and regulations. What is the important criteria to consider when analyzing science to ensure it is sound? What are appropriate guidelines for distinguishing good science from bad science?

12:00–1:15 PM
Luncheon Address 

1:30–2:30 PM 
Illicit Trade of Tobacco and Nicotine Products
This session will educate attendees on illicit trade patterns for traditional cigarettes and vapor products in the United States and abroad. Hear from speakers on how the illicit trade of tobacco and nicotine products affects the economy and public health, as well as law enforcement efforts that are being undertaken to address the issues.

2:30–3:30 PM 
Ensuring an Effective Tobacco and Nicotine Regulatory Framework
As scientific study findings, products, and public views constantly evolve and improve, how is FDA’s regulatory framework for tobacco and nicotine products affected? Can the current framework be modernized or improved? How do you strike a balance between regulation and innovation while balance competing interests?

3:30 PM
Conference Adjournment

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Location and Overnight Accommodations

Conference Location

The National Press Club
529 14th Street NW
Washington, DC 20045

Overnight Accommodations

A block of rooms has been reserved at the JW Marriott Hotel, located in walking distance of the conference location. Reservations can be made online. The group rate is $339/night. Reservations must be received by September 20, 2018 in order to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

Driving, Parking, and Public Transportation

The National Press Club is closest to the Metro Center stop 13th Street exit. There are several public parking garages nearby. Detailed metro, driving, and parking information can be found here.

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.

2018-08-15T15:29:05+00:00