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Explore the essentials of tobacco law and regulation and gain a comprehensive understanding of the various administrative agencies that impact this industry. Learn about FDA’s Deeming Rule, Premarket Tobacco Applications (PMTA) and Modified Risk Tobacco Product Applications (MRTPA), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

Agenda Highlights

  • FDA’s regulation of tobacco products
  • Pathways to market
  • Product compliance including advertising and promotion requirements
  • FDA’s enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act)
  • Comprehensive Smokeless Tobacco Health Education Act (CSTHEA)
  • Federal Cigarette Labeling and Advertising Act (FCLAA)
  • Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of tobacco law and regulation is needed.

Attendee Resources

These valuable takeaways will be provided onsite:

  • A binder of speaker handouts and related reference materials.
  • An electronic copy of FDA’s Deeming Rule and relevant guidance documents.

Register

Industry & Firms

$1,199
  • +$200 for nonmembers

Non-Profit

$999
  • +$100 for nonmembers

Government

$999
  • +$100 for nonmembers

Academic

$999
  • +$100 for nonmembers

Student

$99
  • student registration
Register Now

Build On Your Knowledge

Add the two-day Tobacco and Nicotine Products Regulation and Policy Conference to your course registration to gain a more advanced understanding of these complex topics 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.

Agenda

subject to change

Curriculum Advisors:
Azim Chowdhury, Partner, FDA Group (Tobacco, E-Vapor, Food, Packaging), Keller and Heckman LLP
Dean Cirotta, President & COO, EAS Consulting Group, LLC
Bryan Haynes, Partner, Troutman Sanders LLP

 

Wednesday, October 24

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements

8:35–10:00 AM
Overview of Tobacco Law and Regulation
Benneville (Ben) Haas, Partner, Latham & Watkins LLP
Nathan Beaton, Associate, Latham & Watkins LLP

10:00–10:30 AM
The Public Health Standard
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative

10:30–10:45 AM
Networking and Refreshment Break 

10:45–11:30 AM
The Deeming Regulations
Bryan Haynes, Partner, Troutman Sanders LLP

11:30 AM–12:30 PM
Pathways to Market
Valerie Solomon
, Managing Counsel, R&D and Regulatory, RAI Services Company

12:30–1:30 PM
Networking Lunch

1:30–2:00 PM
Pathways to Market: Part II
Deborah Sholtes, Division Director, Office of Science, Division of Regulatory Science Informatics, Center for Tobacco Products, FDA
Jeff Smith, Program Manager, Informatics, Office of Science, Division of Regulatory Science Informatics, Center for Tobacco Products, FDA

2:00–3:00 PM
Product Compliance
Azim Chowdhury, Partner, Keller and Heckman LLP

3:00–3:30 PM
Refreshment Break

3:30–4:30 PM
Inspections and Enforcement
Seth A. Mailhot, Partner, Michael Best & Friedrich LLP

4:30–5:15 PM
Interacting with Regulatory Agencies
Parker D. Kasmer
, Associate, Sidley Austin LLP
William A. McConagha, Partner, Sidley Austin LLP

5:15 PM
Adjournment

Join us for a reception on October 25 for the Tobacco and Nicotine Products Conference. 

Enhance Your Career

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, Virginia, and North Carolina. 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.

Pennsylvania: approved for 7.0 CLE credit hours
Ohio: approved for 7.0 CLE credit hours
North Carolina: approved for 6.75 CLE credit hours

 

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 are available.

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

2018-10-16T09:48:26+00:00