2020 Course Update

FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the 2020 Introduction to Tobacco Law and Regulation Course will be a completely virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with leading tobacco and nicotine product experts. Be sure to check the conference website regularly for additional announcements and updates.

Overview

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.

Register

Industry & Firms

$1099
  • +$200 for non-members

Non-Profit

$899
  • +$100 for non-members

Government

$899
  • +$100 for non-members

Academic

$899
  • +$100 for non-members

Student

$99
  • full-time students only
Register Now

 

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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.

Preliminary Agenda

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

12:15 – 12:30 PM
Break

12:30 – 1:20 PM
II. Pathways to Market

1:20 – 1:25 PM
Transition

1:25 – 1:45 PM
III. The Public Heath Standard

1:45 – 2:00 PM
Break

2:00 – 2:45 PM
IV. Pre- and Post-Market Product Compliance

2:45 – 2:50 PM
Transition

2:50 – 3:30 PM
V. Food and Drug Administration (FDA) Inspections and Enforcement

3:30 – 3:45 PM
Break

3:45 – 4:45 PM
VI. Panel Discussion and Q&A: Hot Topics and Current Issues

4:45 PM
Closing Remarks and Adjournment

Continuing Legal Education

FDLI applies for CLE credits in Ohio 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.