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.

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.

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Industry & Firms

$999
  • +$200 for non-members
  • +100 after 8/13/2020
  • +100 after 9/17/2020

Non-Profit

$799
  • +$200 for non-members
  • +100 after 8/13/2020
  • +100 after 9/17/2020

Government

$799
  • +$200 for non-members
  • +100 after 8/13/2020
  • +100 after 9/17/2020

Academic

$799
  • +$200 for non-members
  • +100 after 8/13/2020
  • +100 after 9/17/2020

Student

$99
  • student registration
  • full-time students only
  • transcripts required
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Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 6th Edition to have an overview of the key legal and regulatory topics at your fingertips.  Order your copy today and it will be shipped directly to your office.

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.

Preliminary Agenda

subject to change

 

Wednesday

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

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

10:15 – 11:00 AM
II. The Deeming Regulation

11:00 – 11:30 AM
III.  The Public Health Standard

11:30 AM – 12:30 PM
Networking Lunch

12:30 – 1:30 PM
IV.  Pathways to Market

1:30 – 2:30 PM
V.  Pre- and Post-Market Product Compliance for Each Product Type

 2:30 – 2:45 PM
Networking and Refreshment Break

2:45 – 3:30 PM
VI.  Food and Drug Administration (FDA) Inspections and Enforcement

3:30 – 4:30 PM
VII.  Panel Discussion:  Hot Topics and Current Issues

4:30 PM
Closing Remarks and 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

Crowell & Moring
1001 Pennsylvania Avenue NW
Washington, DC 20004

Overnight Accommodations

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