Why Attend

Agenda

Location & CLE

Tuesday, October 17

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

FDLI Welcome and Announcements
Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI

I. The Family Smoking Prevention and Tobacco Control Act (TCA), the Deeming Regulation and Synthetic Nicotine Authority
Vanessa 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. Additional Authorities
    1. Overview of the Deeming Regulation
    2. Products to which it applies
    3. Distinction between components and accessories
    4. Requirements for covered products
    5. FDA’s authority over synthetic nicotine

11:30 AM–12:30 PM     
II. Pathways to Market and Related FDA Processes
Elizabeth Oestreich, Senior Vice President, Regulatory Compliance, Greenleaf Health, Inc.

  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 is appropriate for the protection of public health?
    2. Definitions
    3. Data needed in applying public health standard
  2. Consumer Information and Population Monitoring
    1. Data on tobacco and nicotine product use in the US
    2. Research that informs regulation (PATH, NYTS, etc.)
    3. Why regulation of these products is/remains important

1:40–2:40 PM
IV.  Product Compliance
Philip 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

3:00–3:50 PM
V.  FDA Inspections and Enforcement
Benjamin K. Wolf, Senior Associate, Alston & Bird LLP

  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

4:00–5:00 PM
VI.  Hot Topics and Current Issues Panel Discussion
Kellsi Booth, Vice President, Regulatory Affairs, Turning Point Brands, Inc.
Vanessa Fulton, Associate, Kleinfeld, Kaplan & Becker, LLP
Barry S. Schaevitz, Partner, Fox Rothschild LLP

  1. PMTA orders and pending applications
  2. Pending Litigation and Recent Rulings
  3. Reagan-Udall Report
  4. Proposed Product Standards for Menthol and Characterizing Flavors
  5. Proposed Nicotine Cap for Combustible Products
  6. Q & A

5:00 PM
Adjournment