Introduction to Tobacco Law and Regulation

October 15, 2024   Virtual Course

Agenda

Agenda Subject to Change
All Times are in Eastern Time

Tuesday, October 15

10:00–11:20 AM 
FDLI Welcome and First Session

FDLI Welcome and Announcements
Paige Samson, Interim Director, Educational Programs and Director, Publications, FDLI

I. The Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Regulation
Vanessa K. Fulton, Associate, Kleinfeld, Kaplan & Becker, LLP

  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. 2022 amendment covering synthetic nicotine
  3. Overview of the Deeming Regulation
    1. Newly deemed products
    2. Distinction between components and accessories
    3. Requirements for covered products
  4. PACT Act
  5. Master Settlement Agreement

11:30 AM–12:30 PM     
II. Pathways to Market and Related FDA Processes
Nathan A. Beaton, Associate, Latham & Watkins LLP

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

 

12:30–1:00 PM
Break

1:00–1:30 PM
III. The Public Health Standard
Maham Akbar, Director, Public Policy, Truth Initiative

  1. Overview of public health standard
    1. What does “appropriate for the protection of public health” mean?
    2. Definitions
    3. Data needed to apply the public health standard
  2. Consumer information and population monitoring
    1. Data on tobacco and nicotine product use in the United States
    2. Research that informs regulation (PATH, NYTS, etc.)
    3. Why regulation of these products remains important 

1:40–2:40 PM
IV. Product Compliance
Philip Z. Langer, Associate, Fox Rothschild LLP

  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

2:40–3:00 PM
Break

3:00–4:00 PM
V. Inspections and Enforcement
Benjamin K. Wolf, Senior Associate, Alston & Bird LLP

  1. Overview of Food, Drug, and Cosmetic Act (FDCA) inspection power
  2. Inspections of manufacturing facilities
  3. Inspections of retail establishments
  4. Warning letters and other enforcement tools
  5. Inter-agency enforcement coordination

4:10–5:00 PM
VI. Recent Developments and Hot Topics Panel Discussion
Vanessa K. Fulton, Associate, Kleinfeld, Kaplan & Becker, LLP
Kellsi Booth, Vice President, Regulatory Affairs, Turning Point Brands, Inc.
Beth G. Oliva, Partner, Fox Rothschild LLP and Member, FDLI Board of Directors

  1. Recent PMTA decisions, including the NJOY and Vuse Marketing Granted Orders (MGOs)
  2. Pending litigation, including SCOTUS granting cert. for the Triton case
  3. Proposed product standards for menthol and characterizing flavors
  4. Audience Q&A

5:00 PM
Adjournment