Tobacco Products

Tobacco Product Application Review - A Public Meeting

October 22-23, 2018
8:30 a.m. to 4:30 p.m. on October 22, and 8:30 to 3 p.m. on October 23

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

Proposed Meeting Agenda

Meeting Objective:

This meeting is intended to improve public understanding and 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):

  • Substantial Equivalence Reports (SE Reports) – Section 905(j)
  • Exemption Requests (Ex Reqs) – Section 905(j)
  • Premarket Tobacco Product Applications (PMTAs) – Section 910
  • Modified Risk Tobacco Product Applications (MRPTAs) – Section 911

Topics to be addressed in the meeting include:

  • Overview of the tobacco product marketing applications types
  • Information that should be included in a tobacco product marketing application
  • Administrative processes involved in the submission and review of a tobacco product marketing application
  • Other topics relevant to the submission of tobacco product marketing applications, including Tobacco Product Master Files, meeting requests, Grandfathered review, and Environmental Assessments

FDA will present information about the tobacco product application review programs 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 and regulated industry representatives to discuss the topics.

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

Who Should Attend this Meeting?

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.

Register to Attend or View a Live Webcast of the Workshop:

If you wish to attend the workshop in-person or by webcast, you must register no later than October 5, 2018. Registration is free.

Please submit registration requests online. These requests must include the prospective attendee’s name, title, affiliation, and contact information. Both in-person seating and webcast viewership are limited, so early registration is recommended. FDA may limit the number of registrants from a single organization, as well as the total number of participants, if registration reaches full capacity.

Confirmation of registration will be emailed to you.

Onsite registration may be allowed if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration on this webpage.

Archived Webcast and Transcripts:

FDA will post the webcast along with complete transcripts on this website as soon as they are available.

Panelists:

FDA is interested in gathering information and perspectives from stakeholders on the topics to be discussed. 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

Panelists will discuss the presentations and issues listed above.

FDA Invites Public Comments on Tobacco Product Marketing Application Review

Docket for submitting public written comments:
Regardless of attendance at the public meeting, interested persons are invited to submit comments and other information to the docket.

Key Dates:

  • Deadline for Requests to Serve as a Panelist: August 31, 2018
  • Registration Deadline: extended to October 5, 2018
  • Submit comments by: December 7, 2018

Special Accommodations:

If you need special accommodations because of disability, please email Workshop.CTPOS@fda.hhs.gov, or call 1-877-287-1373 (Option 5) at least seven days before the meeting.

Contact for Questions:

Telephone: 1-877-287-1373 (Option 5)
e-mail: Workshop.CTPOS@fda.hhs.gov

Page Last Updated: 10/05/2018
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