Tobacco Products

Tobacco Product Application Review - A Public Meeting

Hilton Washington DC/Rockville Hotel & Executive Meeting Center
1750 Rockville Pike
Rockville, MD 20852

October 22-23, 2018


On this page:


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.


Agenda and Presentations

Watch video webcast
Transcripts:

Day 1: October 22, 2018

8:30 am 

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)

8:45 am 

Session 1:
Request for Exemption from Substantial Equivalence (Exemption Request, EX REQ): Jennifer Schmitz – Office of Science (OS)/Division of Regulatory Project Management (PDF)

Substantial Equivalence: Cristi Stark – OS/Division of Regulatory Project Management (PDF)

9:30 am

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

10:30 am 

Session 2
Premarket Tobacco Product Application (PMTA) Review Process: Nicholas Hasbrouck - OS/Division of Regulatory Project Management (PDF)

Modified Risk Tobacco Product (MRTP) Application Review Process: Ebony Jackson – OS/Division of Regulatory Project Management (PDF)

11:35 am

Session 3
Pre-Submission Meetings with the Office of Science: Barbara Banchero – OS/Division of Regulatory Project Management (PDF)

Tobacco Product Master Files (TPMFs): Sarah Vichensont – OS/Division of Regulatory Project Management (PDF)

1:15 pm

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 

1:45 pm

Session 4
Information and Resources on Application Review Programs: Sharyn Miller – OS/Division of Regulatory Project Management (PDF)

CTP Electronic Submissions Standards and Activities: Jeff Smith – OS/Division of Regulatory Science Informatics  (PDF)

2:20 pm

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 

3:05 pm

Session 5
Environmental Assessments & Claims of Categorical Exclusion: Hoshing Chang – OS/Division of Nonclinical Science (PDF)

Transfer of ownership - Renee Coneway – OS/Division of Regulatory Project Management (PDF)

4:05 pm

Session 5
Panel Discussion:
Moderator: Eshael Johnson
OCD Tony Abboud – Vapor Technology Association
Karen Cook – ITG Brands Christie  

Day 2: October 23, 2018 

8:30 am 

Welcome: Karin Rudolph – OCD 

8:40 am 

Session 6
Content Focus: Request for Exemption from Substantial Equivalence (Exemption Requests) - Matt Walters-OS/Division of Product Science (PDF)

SE Report Content: Colleen Rogers – OS/Division of Product Science
Todd Cecil - OS/Division of Product Science (PDF) 

9:45 am 

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 

10:45 am 

Session 7
Premarket Tobacco Product Application Content Overview: Iilun Murphy – OS/Division of Individual Health Science (PDF)

Tobacco Product Application Review: Modified Risk Tobacco Product Applications (MRTPAs): Ben Apelberg – OS/Division of Population Health Science (PDF)

1:20 pm 

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

2:05 pm 

Session 8
Open Discussion on Newly Deemed Tobacco Products

2:25 pm 

Session 8
Panel Discussion
Moderator: Eshael Johnson - OCD
David Graham – NJOY
Drew Newman – J.C. Newman Cigar

2:55 pm 

Closing Remarks: Joe Murillo
Altria Matt Holman – OS


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, the FDA recently began including such appendices with acknowledgment and notification letters related to SE reports.
The information included in these appendices reflects deficiencies frequently seen in previous SE Reports that FDA has reviewed:


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.

Temporary Compliance Waiver Notice

At the time of initial posting, the documents may not be fully accessible to readers using assistive technology. Fully accessible versions of the documents are in preparation and will be posted as soon as they are ready. We regret any inconvenience that this may cause our readers.

In the event you are unable to read the documents or portions thereof, please email Workshop.CTPOS@fda.hhs.gov
 

 

Page Last Updated: 12/10/2018
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