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.

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Industry & Firms

$999
  • +$200 for non-members
  • +$100 after 8/29/2019

Non-Profit

$799
  • +$100 for non-members
  • +$100 after 8/29/2019

Government

$799
  • +$100 for non-members
  • +$100 after 8/29/2019

Academic

$799
  • +$100 for non-members
  • +$100 after 8/29/2019

Student

$99
  • full-time students only
  • transcripts required
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 – 8:30 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

10:00 – 10:30 AM
The Public Health Standard

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

10:45 – 11:30 AM
The Deeming Regulations

11:30 AM – 12:30 PM
Pathways to Market

12:30 – 1:30 PM
Networking Lunch

1:30 – 2:00 PM
Pathways to Market: Part II

2:00 – 3:00 PM
Product Compliance

3:00 – 3:30 PM
Refreshment Break

3:30 – 4:30 PM
Inspections and Enforcement

4:30 – 5:15 PM
Interacting with Regulatory Agencies

5:15 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.

Location and Overnight Accommodations

Course Location

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

Overnight Accommodations

A block of rooms has been reserved at the JW Marriott for conference attendees at the special group rate of $329/night, not inclusive of taxes. The JW Marriott is a short walk from the National Press Club. Reservations can be made online and must be received by September 27, 2019 to receive the group rate. After this date, it is at the hotel’s discretion whether to accept additional reservations, which will be subject to prevailing rates and availability.

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