The Troutman Sanders Tobacco Team will attend a meeting at the Food and Drug Administration Center for Tobacco Products on “Deemed Tobacco Product Applications” October 28-29, 2019.
The meeting is intended to provide information on the agency’s expectations for tobacco product applications, with a particular focus on deemed tobacco products, including electronic nicotine delivery systems, cigars, pipe and waterpipe. This will include product review policies, procedures and general scientific principles. The information is intended to improve public understanding and to assist businesses considering submitting marketing applications under the Family Smoking Prevention and Tobacco Control Act, including premarket tobacco applications (PMTAs), substantial equivalence reports (SE Reports) and requests for exemption from substantial equivalence (EX Requests).
Topics to be addressed in the meeting include:
- Overview of the tobacco product marketing application pathways
- Information that should be included in these applications
- Administrative processes involved in the submission and review of these applications
- Other topics relevant to the submission of these applications, including communications with FDA during the application review process, the use of tobacco product master files and electronic submission resources and tools.