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Tobacco Product Application Review - A Public Meeting


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Meeting Objective:

This meeting was intended to improve public understanding and to seek feedback on the policies and processes for the submission and review of tobacco product marketing applications, including the general scientific principles relevant to various application pathways, in order to assist persons considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The meeting was not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review.

Meeting attendees included tobacco product manufacturers, including small business tobacco manufacturers, importers, distributors, wholesalers, and retailers; scientific and medical experts; federal, state, and local government agencies; and other interested stakeholders, such as academic researchers and public health organizations.


Day 1: October 22, 2018

Transcript:

Welcome: Mitch Zeller – FDA Center for Tobacco Products

Opening Remarks: Jeff Walker – Teton Regulatory Sciences

Overview of the Meeting: Eshael Johnson – Office of the Center Director (OCD)

Session 1:

Panel Discussion: 
Moderator: Eshael Johnson
OCD Brittani Cushman – Turning Point Brands
Thomas Lindegaard – Scandinavian Tobacco Group
Patrick Murphy – RAIS
Rosanna Beltre – OS/Division of Regulatory Project Management
Cristi Stark – OS/Division of Regulatory Project Management

Session 2:

Session 3:

Panel Discussion:
Moderator: Karin Rudolph
OCD Bryan Haynes – Troutman Sanders
Patricia Miller – Altria
Russell Wolz – Enthalpy Analytical
Marcella Dolling - OS/Division of Regulatory Project Management
Joanna Randazzo – OS/Science Policy Branch 

Session 4:

Panel Discussion: 
Moderator: Karin Rudolph
Leann Campbell – RAIS
Paisley Cameron – JTI
Anuschka Merson – ITG Brands
Sharyn Miller – OS/Division of Regulatory Project Management
Deborah Sholtes – OS/Division of Regulatory Science Informatics 

Session 5

Panel Discussion:
Moderator: Eshael Johnson
OCD Tony Abboud – Vapor Technology Association
Karen Cook – ITG Brands Christie  

Day 1 Presentation Recordings

Session 1


Sessions 2 & 3


Sessions 3 & 4 & 5


Day 2: October 23, 2018 

Transcript:

Welcome: Karin Rudolph – OCD 

Session 6

Panel Discussion
Moderator: Eshael Johnson - OCD
Robert Buell – Altria
Thomas Lindegaard – Scandinavian Tobacco Group
Marc Scheineson – Alston & Bird
Todd Cecil – OS/Division of Product Science
Colleen Rogers – OS/Division of Product Science Matt Walters – OS/Division of Product Science 

Session 7

Panel Discussion
Moderator: Karin Rudolph – OCD
Debbie Hayden – SMNA
Matt Myers – Campaign for Tobacco-Free Kids Elaine Round – RAIS
Mohamadi Sarkar – Altria
Ben Apelberg – OS/Division of Population Health Science
Priscilla Callahan-Lyon – OS/Division of Individual Health Science

Session 8
Open Discussion on Newly Deemed Tobacco Products

Panel Discussion
Moderator: Eshael Johnson - OCD
David Graham – NJOY
Drew Newman – J.C. Newman Cigar

Closing Remarks: Joe Murillo
Altria Matt Holman – OS

Day 2 Presentation Recordings

Session 6


Sessions 6 & 7


Sessions 7 & 8


Additional Materials Discussed at the Meeting

SE Report Appendices

To help companies prepare a Substantial Equivalence (SE) report for submission and to avoid common deficiencies that may result in an unfavorable decision on an application, the FDA has posted appendices by product type containing common issues the agency has identified in previous SE reports. As noted at the meeting, FDA is including such appendices with acknowledgment and notification letters related to SE reports.


Panelists:

We invited nominations for panelists to address information pertaining to the following topics related to tobacco product marketing application review:

  • Application submission and review, including pre-submission meetings and preparation of electronic submissions
  • Use of Tobacco Product Master Files (TPMFs)
  • Grandfathered review
  • Environmental Assessment (EA) review
  • Scientific content and evaluation of Exemption Requests and SE Reports
  • Scientific content and evaluation of PMTAs and MRTPAs

Tony Abboud
Executive Director
Vapor Technology Association

Robert Buell
Sr. Assistant General Counsel, Regulatory Affairs
Altria Client Services LLC

Paisley Cameron
Director, Scientific & Regulatory Affairs
Japan Tobacco International USA

Leanne Campbell, PhD
Senior Manager, eSubmissions Scientific & Regulatory Affairs
RAI Services Company

Karen Cook
Manager of Regulatory Affairs
ITG Brands, LLC

Brittani Cushman
Senior Vice President, External Affairs
Turning Point Brands, Inc.

David M Graham, MPA
Chief Impact Officer
NJOY

Debbie Hayden
Director, Product Development
Swedish Match

Bryan Haynes
Partner,
Troutman Sanders LLP

Patricia I. Kovacevic, JD, MA
Legal, regulatory and strategy consultant

Thomas Lindegaard
Senior Vice President, Scientific and Regulatory Affairs
Scandinavian Tobacco Group

Anuschka Merson
Manager of Regulatory Science
ITG Brands, LLC

Patricia Miller, JD
Sr. Director, External Reduced Risk Products Regulatory Integration
Regulatory Affairs,
Altria Client Services, Inc.

Jose Luis Murillo
Senior Vice President Regulatory Affairs
Altria Client Services LLC

Patrick Murphy, RAC (U.S.)
Senior Director, Submissions & Engagement Scientific & Regulatory Affairs
RAI Services Company

Matthew L. Myers
President
Campaign for Tobacco-Free Kids

Drew Newman
General Counsel and Great-Grandson of the Founder
J.C. Newman Cigar Company

Christie Young Powell, PhD, MBA
Master Scientist, Scientific & Regulatory Affairs
RAI Services Company

Elaine K. Round, PhD
Senior Director, Scientific & Regulatory Affairs
RAI Services Company

Mohamadi Sarkar, MPharm, PhD, FCP
Fellow, Scientific Strategy Altria Client Services LLC.

Marc J. Scheineson, Esq.
Alston & Bird LLP

Jim Solyst
Vice President, Federal Regulatory Affairs
Swedish Match North America

Jeffrey P. Walker, MD
CEO
Teton Regulatory Sciences

Russell L. Wolz, PhD
Senior Project Manager /
Enthalpy Analytical, Inc.

Benjamin Apelberg, PhD, MHS
Director, Division of Population Health Science, OS

Barbara Banchero
Regulatory Health Project Manager, DRPM, OS

Rosanna Beltre, MPH
Deputy Director, DRPM, OS

Kimberly A. Benson, PhD
Director, Division of Nonclinical Science (DNCS), OS

Todd Cecil, PhD
Associate Director, Division of Product Science, OS

Priscilla Callahan-Lyon, MD
Deputy Director, Division of Individual Health Science, OS

Hoshing Chang, PhD
Chief, Environmental Science, DNCS, OS

Renee Coneway, MBA
Lead Program Analyst, DRPM, OS

Marcella (White) Dolling, MS, MBA
Branch Chief, DRPM, OS

Nicholas Hasbrouck
Regulatory Health Project Manager, DRPM, OS

Matthew R. Holman, PhD
Director, Office of Science

Ebony Jackson, MPH
Regulatory Health Project Manager, DRPM, OS

Eshael M. Johnson, MS
Director, Stakeholder Relations, OCD

Sharyn E. Miller, MPS
Regulatory Health Project Manager, DRPM, OS

Iilun Murphy, MD
Director, Division of Individual Health Science, OS

Joanna C. Randazzo, DC
Lead Science Policy Analyst, OS

Colleen K. Rogers, PhD
Director, Division of Product Science, OS

Karin L. Rudolph, MA
Policy Analyst, Stakeholder Relations, OCD

Jennifer Schmitz, MPH
Regulatory Health Project Manager, DRPM, OS

Deborah Sholtes, MS
Branch Chief, Division of Regulatory Science Informatics, OS

Dale C. Slavin, PhD
Senior Science Policy Analyst, OS

Jeff K. Smith
eSubmissions Team Lead, Division of Regulatory Science Informatics, OS

Cristi Stark, MS
Director, DRPM, OS

Sarah Vichensont, MPH, CHES, GWCPM
Regulatory Health Project Manager, DRPM, OS

CDR Matthew J. Walters, PhD, MPH
Deputy Director, Division of Product Science, OS

Mitch Zeller, JD
Director, Center for Tobacco Products

DRPM – Division of Regulatory Project Management
OCD – Office of the Center Director
OS –  Office of Science


Questions about your submissions?

Contact your Regulatory Health Project Manager.


Additional Resources

 
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