Why Attend

Last Year’s Agenda

 

Location & CLE

October 26, 2021

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