Explore the essentials of tobacco and nicotine 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.

Register Now

Industry & Firms

$1,199
  • +$200 for non-members

Non-Profit

$999
  • +$100 for non-members

Government

$999
  • +$100 for non-members

Academic

$999
  • +$100 for non-members

Student

$99
  • full-time students only
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

Wednesday, October 23

8:00 – 8:55 AM
Registration and Continental Breakfast

8:55 – 9:00 AM
FDLI Welcome and Announcements
Steven Leslie, Assistant Director, Educational Programs, FDLI

9:00 – 10:00 AM
I.  Overview of Tobacco and Nicotine Products Law and Regulation
J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP

10:00 – 10:15 AM
Networking and Refreshment Break

10:15 – 11:15 AM
II. The Deeming Regulation
Beth G. Oliva, Partner, Fox Rothschild LLP

11:15 AM – 12:00 PM
III.  The Public Health Standard
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative
Swati Rawani, Staff Attorney, Campaign for Tobacco-Free Kids

12:00 – 1:00 PM
Networking Lunch

 

1:00 – 2:00 PM
IV.  Pathways to Market

Azim Chowdhury, Partner, Keller and Heckman LLC
Kathryn C. Skaggs, Associate, Keller and Heckman LLC
Jeffrey Smith, Regulatory Health Information Specialist, Center for Tobacco Products (CTP), Food and Drug Administration (FDA)

2:00 – 3:00 PM
V.  Pre- and Post-Market Product Compliance for Each Product Type
Tara Couch, Senior Director of Dietary Supplement and Tobacco Services, EAS Consulting Group

3:00 – 3:15 PM
Networking and Refreshment Break

3:15 – 4:00 PM
VI.  Food and Drug Administration (FDA) Inspections and Enforcement
Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP

4:00 – 5:00 PM
VII.  Hot Topics and Current Issues
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative
Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Beth G. Oliva, Partner, Fox Rothschild LLP
Moderated by Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health

5:00 PM
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.

Pennsylvania: approved for 6.5 CLE credit hours

 

Location and Overnight Accommodations

Course Location

National Press Club
529 14th St. NW, Washington, DC 20045

Overnight Accommodations

The FDLI room block at the JW Marriott is sold out.  A limited number of rooms are available at an extended group rate of $459/night, not inclusive of taxes.  Contact Cathy Kiss for availability.

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