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

$1599
  • +$500 for non-members

Non-Profit

$999
  • +$100 for non-members

Government

$999
  • +$100 for non-members

Academic

$999
  • +$100 for non-members

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.

Agenda

subject to change

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

11:05 AM – 12:05 PM
I. The Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Regulation

  1. Brief history of tobacco and nicotine product regulation in the United States
  2. Overview of Family Smoking Prevention and Tobacco Control Act (TCA)
    1. Terms and Definitions
    2. Section-by-Section Overview
  3. Overview of the Deeming Regulation
    1. Products to which it applies
    2. Distinction between components and accessories
    3. Requirements for covered products

Nathan A. Beaton, Associate, Latham & Watkins LLP

12:10 – 1:00 PM
II. Pathways to Market

  1. Grandfathered products
  2. Substantial Equivalence
  3. Substantial Equivalence exemption
  4. Premarket Tobacco Applications (PMTAs)
  5. Modified Risk Tobacco Product (MRTP) applications

Benjamin K. Wolf, Senior Associate, Alston & Bird LLP

1:00 – 1:30 PM
Break

1:30 – 1:55 PM
III. The Public Heath Standard

  1. Research on health consequences of tobacco and nicotine product use
    1. Data on tobacco and nicotine product use in the US
    2. Why regulation of these products is/remains important
  2. Overview of public health standard
    1. What is the public health standard?
    2. Definitions
    3. Data needed in applying public health standard

Stacey Gagosian, Managing Director of Public Policy, Truth Initiative

2:00 – 2:50 PM
IV. Product Compliance

  1. Labeling and warning requirements
  2. Product registration and ingredient submission
  3. User Fees and Tobacco Taxation
  4. Marketing and advertising limitations and requirements
  5. Retailer requirements
  6. Product standards

Kathryn C. Skaggs, Partner, Keller and Heckman LLC

2:50 – 3:10 PM
Break

3:10 – 4:00 PM
V. Food and Drug Administration (FDA) Inspections and Enforcement

  1. Overview of Food, Drug, and Cosmetic Act (FDCA) Inspection Power
  2. FDA Inspections of Manufacturing Facilities
  3. FDA Inspections of Retail Establishments
  4. FDA Warning letters and other enforcement tools

Seth Gitner, Associate, Saul Ewing Arnstein & Lehr LLP

4:05 – 4:50 PM
VI. Panel Discussion and Q&A: Hot Topics and Current Issues

  1. PMTA orders and pending applications
  2. MRTP orders and pending applications
  3. Proposed Menthol and Characterizing Flavor Bans
  4. Pending Litigation
  5. Q & A

Azim Chowdhury, Partner, Keller and Heckman LLP
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative
Moderated by Steven Leslie, Deputy Director, Educational Programs, FDLI

4:50 PM
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.