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On this page: 

• Meeting Objective
• Who Should Attend this Meeting?
• Registration to Attend or View a Live Webcast of the Meeting
• Archived Webcast and Transcripts
• Special Accommodations
• Contact for Questions

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Meeting Objective

This meeting will provide 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 has observed in reviewing applications over the past three years. The meeting will provide an opportunity for stakeholder engagement and will improve public understanding and assist persons considering submitting SE Reports or PMTAs. 

Topics that will be addressed during the meeting include:

• 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
• Review issues related to product characterization, nonclinical science, abuse liability, and population health 

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

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

Who Should Attend this Meeting? 

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

Registration to Attend or View a Live Webcast of the Meeting  

The meeting will be in-person, but with a virtual option. We encourage you to register and submit questions by Oct. 6, 2023, at 11:59 p.m. EDT; registration is free. 

Please submit electronic requests to register at https://www.eventbrite.com/e/premarket-tobacco-product-application-processes-a-public-meeting-tickets-723402786207. Requests for registration must include the prospective attendee’s name, title, affiliation, and contact information.

Archived Webcast and Transcripts  

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

Special Accommodations 

If a reasonable accommodation is needed in order to fully participate in this event, please notify Serina Hunter-Thomas at [email protected]. Requests for sign language interpretation should be made at least 7 days before the public meeting. A request for ASL services should be sent directly to the FDA Interpreting Services Staff email account: [email protected].

Contact for Questions

• Telephone: 1-877-287-1373
• e-mail:  [email protected]