Clarifying Expectations

The Food and Drug Administration’s (FDA) Center for Tobacco Products is holding a public meeting today and tomorrow in Silver Spring, Maryland, USA, to provide information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, waterpipes and electronic nicotine-delivery systems including e-liquids and electronic cigarettes) including product review policies, procedures and general scientific principles.

The information is intended to improve public understanding and assist persons considering submitting marketing applications for tobacco products under the Federal Food, Drug and Cosmetic Act, including pre-market tobacco product applications, substantial equivalence (SE) reports and the exemption from SE.

Topics to be addressed in the meeting include:

  • Overview of the tobacco product marketing application pathways
  • 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 communications between the FDA and the industry during an application review process, use of tobacco product master files as well as electronic submission resources and tools.

To view the public meeting online, click here.