FDA recently finalized its “Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS)” guidance. FDA also issued a marketing order for a non-combustible tobacco product, IQOS, in accordance with the guidance. In this session, panelists will engage in a detailed discussion of both the finalized guidance and the marketing order.

Building off the previous session, panelists will discuss the future of PMTAs in light of recent developments.  The discussion will focus on the particular challenges faced by ENDS manufacturers as well as the public health perspective on the PMTA process.

The Tobacco Control Act (TCA) establishes a novel population impact standard for reviewing applications for new products and health claims. In this session, panelists will discuss computational modeling of tobacco product impacts on public health, various types of modeling systems used for nicotine products, and what factors should be considered or included when utilizing these models to support an application.

The session will feature an overview of the key elements of FDA’s proposed rule for substantial equivalence, as well as a question and answer session.

Currently, if a tobacco or nicotine product is modified or altered after a PMTA is submitted, a new PMTA would need to be submitted for the altered product. This results in substantial costs to manufacturers and restricts the number of reduced risk products in the marketplace by hindering innovation. In this session, panelists will discuss post-application product modifications in light of FDA’s proposed rule for PMTAs, as well as potential alternatives and their respective benefits and drawbacks.

From cigarettes to cigars to chewable tobacco to e-cigarettes, flavored tobacco and nicotine products are widely available…for now. This session will feature a comprehensive discussion of flavors, including why manufacturers use flavors, responsible marketing of flavored products, how flavors fold into public health goals, and FDA guidance on and enforcement discretion of flavored products.