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.

 

Register

Industry & Firms

$1299
  • +$500 for non-members
  • +$100 after 10/15/21

Non-Profit

$799
  • +$100 for non-members
  • +$100 after 10/15/21

Government

$799
  • +$100 for non-members
  • +$100 after 10/15/21

Academic

$799
  • +$100 for non-members
  • +$100 after 10/15/21

Student

$99
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Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th 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.

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.

Last Year’s Agenda

11:00 – 11:05 AM
FDLI Welcome and Announcements

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 – 1:55 PM
III. The Public Heath Standard

1:55 – 2:10 PM
Break

2:10 – 2:55 PM
IV. Product Compliance

2:55 – 3:00 PM
Transition

3:00 – 3:45 PM
V. Food and Drug Administration (FDA) Inspections and Enforcement

3:45 – 4:00 PM
Break

4:00 – 5:00 PM
VI. Panel Discussion and Q&A: Hot Topics and Current Issues

5:00 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.