Mark your calendars–the U.S. Food and Drug Administration is holding a public meeting on deemed tobacco product applications. Scheduled for October 28-29, 2019, the meeting is organized by the Center for Tobacco Products and will be held at the White Oak Campus: The Great Room located at 10903 New Hampshire Ave., Building 31 Conference Room, in Silver Spring, MD.
The meeting was created to provide information on the FDA’s expectations for tobacco product application with a focus on deemed tobacco products. That means those who manufacture cigars, water pipes, pipe tobacco, and electronic nicotine delivery systems (ENDS) will want to make plans to attend or follow this meeting. The FDA also says this meeting will be helpful to importers, distributors, wholesalers, retailers; scientific and medical experts; federal, state, and local government agencies; and other interested stakeholders, such as academic researchers and public health organizations.
Some of the topics to be discussed include product review policies, procedures and general scientific principles that will be useful for submitting marketing applications for tobacco products, as required by the Federal Food, Drug and Cosmetic Act (FD&C Act). Under this act, manufacturers of covered tobacco products are expected to submit premarket tobacco product applications (PMTAs), exemption from substantial equivalence (EX Requests), and substantial equivalence reports (SE). The meeting will provide an overview of tobacco product marketing application pathways, the information that should be included in a tobacco product marketing application, administrative processes involved in the submission and review of tobacco product marketing application, and other topics relevant to the submission of tobacco product marketing applications. No new policies or interpretations regarding tobacco product marketing applications and their review will be covered.