Explore the essentials of tobacco and nicotine product law and regulation and gain a comprehensive understanding of the various administrative agencies that impact this industry. Learn about FDA’s Deeming Rule, the Public Health Standard, Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product Applications (MRTPs), compliance, enforcement, advertising and marketing, recent and pending litigation, and more. The program will conclude with a discussion of industry hot topics, and all sessions will feature ample time for Q&A. This course provides a foundation for understanding the topics that will be discussed at a more advanced-level during the Tobacco and Nicotine Products Regulation and Policy Conference.

Agenda Highlights

  • FDA’s regulation of tobacco and nicotine products
  • Pathways to market
  • Product compliance including advertising and marketing 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.


Industry & Firms

  • +$200 for non-members


  • +$100 for non-members


  • +$100 for non-members


  • +$100 for non-members


  • full-time students only

A Valuable Reference In Your Preferred Format

Order FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

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.


subject to change


Tuesday, October 20

11:00 – 11:05 AM
FDLI Welcome and Announcements
Steven Leslie, Assistant Director, Educational Programs, FDLI

11:05 AM – 12:15 PM
I. The Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Regulation
J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP

12:15 – 12:30 PM

12:30 – 1:20 PM
II. Pathways to Market
Ben Wolf, Associate, Alston & Bird LLP

1:20 – 1:25 PM

1:25 – 1:55 PM
III. The Public Heath Standard
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Swati Rawani, Staff Attorney, Campaign for Tobacco-Free Kids

1:55 – 2:10 PM

2:10 – 2:55 PM
IV. Product Compliance
Kathryn C. Skaggs, Associate, Keller and Heckman LLC

2:55 – 3:00 PM

3:00 – 3:45 PM
V. Food and Drug Administration (FDA) Inspections and Enforcement
Lauren A. Farruggia, Associate, Saul Ewing Arnstein & Lehr LLP

3:45 – 4:00 PM

4:00 – 5:00 PM
VI. Panel Discussion and Q&A: Hot Topics and Current Issues
Lauren A. Farruggia, Associate, Saul Ewing Arnstein & Lehr LLP
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative
J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP
Moderated by Steven Leslie, Assistant Director, Educational Programs, FDLI

5:00 PM
Closing Remarks and Adjournment


Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.