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  4. Premarket Applications: Opportunities for Stakeholder Engagement - A Public Meeting - 10/23/2023
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Event Title
Premarket Applications: Opportunities for Stakeholder Engagement - A Public Meeting
October 23 - 24, 2023


The meeting is free and open to the public.

October 23 - 24, 2023
- ET
- ET

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Meeting Objective

This meeting provided information on the agency’s expectations for Substantial Equivalence Reports (SE Reports) and Premarket Tobacco Product Applications (PMTAs) and information to assist applicants with avoiding problems that CTP had observed in reviewing applications over the past three years. The meeting provided an opportunity for stakeholder engagement to improve public understanding and assist persons considering submitting SE Reports or PMTAs. 

Topics that were addressed during the meeting included:

  • Overview of the SE and PMTA process, changes since the SE and PMTA final rule implementation, and program status
  • Required content and format for PMTAs
  • Reviewed issues related to product characterization, nonclinical science, abuse liability, and population health 

FDA presented information about the SE and PMTA process including process improvements, and observations that may inform further improvements in submissions and the review process. FDA sought feedback from the public and had panels of FDA representatives to discuss various topics. 

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

Meeting Agenda

October 23, 2023


  • Welcome Address and Remarks – Brian King, PhD, MPH 
  • Overview of the Meeting—CDR Avena Russell, MS

9:20am -10:15am Session 1: PMTA: Current Status and Looking Forward 

  • 9:20-9:50am Premarket Tobacco Product Application (PMTA) Overview – Huda Dawood, BS
  • 9:50-10:15am Program Status on PMTAs – Eric Cruz, BS

10:15am - 10:30am – BREAK

10:30am - 11:50am Session 2: Required Content and Format of PMTAs 

  • 10:30-11:10am PMTA Acceptance – Lauren DeBerry, MPH 
  • 11:10-11:30am Tobacco Product Master Files – Sequoia Bacon, MHA
  • 11:30-11:50am CTP and CDISC Tobacco Data Standards Development – Chrissie Cai, MS

11:50am - 1:05pm – LUNCH BREAK 

1:05pm – 1:55pm Session 2 (continued): Required Content and Format of PMTAs 

  • 1:05-1:25pm Electronic Submissions Lessons Learned & Common Errors – Deborah Sholtes, MS 
  • 1:25-1:50pm Product Form Validator Tool for PMTA 4057(b) Form – Sheryl Wood MPH and Fran Weiss, BS

1:50pm- 2:15pm Session 3: Substantial Equivalence: Current Status and Looking Forward

  • 1:50-2:15pm Updates on Substantial Equivalence Reports – Kris VanAmburg  

2:15pm—2:30 pm – BREAK

2:30pm – 4:00pm Panel for Session 1, 2 and 3

  • Closing Remarks – Todd Cecil, PhD

*End of Day 1 ~4:05pm*


October 24, 2023


  • Welcome Address and Remarks – Matthew Farrelly, PhD
  • Brief Overview of Meeting – CDR Avena Russell

8:45am – 10:15am Session 4:  FDA Review – Product Characterization  

  • 8:45-9:15am Best Practices for Submitting Complete Ingredient and HPHC Information in PMTAs – Stephanie Daniels, PhD
  • 9:15-9:45am Extractables and Leachables Evaluation – Rachel Lerebours, PhD and Kristin Wurcel, PhD

9:45am – 10:15am Panel for Session 4 

10:15am -10:30am – BREAK

10:30am – 11:55am Session 5: FDA Review – Behavioral Evidence

  • 10:30-10:50am Recommendations for Abuse Liability Studies – Mollie Miller, PhD
  • 10:50-11:25am Demonstrating Adult Benefit for Flavored ENDS PMTAs – Apostolos Alexandridis, PhD, MPH

11:25am – 11:55am Panel for Session 5 

11:55am – 1:10pm LUNCH BREAK

1:10pm- 2:35pm Session 6: FDA Review – Toxicology

  • 1:10-1:35pm Hazard Identification: Genetic Toxicology Assessment for PMTAs – Challenges and Limitations – Mamata De, PhD
  • 1:35-2:05pm Considerations in Assessing Relative Hazards, Exposures, and Risks between ENDS and other tobacco products – Jonathan Fallica, PhD and Mary Irwin, PhD

2:05pm – 2:35pm PANEL for Session 6 

2:35pm – 2:50pm – BREAK 

2:50pm – 3:55pm Session 7: Questions and Answers with Office of Science Staff


  • Closing Remarks – Benjamin Apelberg, PhD

*End of Day 2 ~4:00pm*

Archived Webcast and Transcripts  

FDA will post the webcast along with complete transcripts when available.

Contact for Questions

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