2024 Food and Drug Law Institute Science Symposium and Policy Conference

On October 23, 2024, Dr. Vergara & Dr. Largo kicked off the Food and Drug Law Institute (FDLI) Tobacco and Nicotine Regulatory Science Symposium with their presentation, “Risk / Benefit Assessment for APPH Determination – Are We There Yet? NJOY^® Case Study.” 

Dr. Vergara opened the discussion by sharing the evidence supporting FDA authorization of NJOY ACE^® products and assessing the benefits and risks for Appropriate for the Protection for Public Heath (APPH). Dr. Largo then discussed the framework for evaluating “added benefit” in the assessment of how flavored products facilitate switching and move adult tobacco consumers down the continuum of risk.

Later at the symposium, Dr. Sarkar moderated the panel “Following the Science–or Lack Thereof–on Tobacco Use Later in Life: Implications for Tobacco Regulatory Policy. During the discussion, panelists shared how public health strategies have primarily focused on the young and middle-aged population and the implications of excluding older adults in research.

The following day at the FDLI Tobacco and Nicotine Products Regulation and Policy Conference, David joined a panel called “Recent State Regulatory and Enforcement activity: Filling the Gaps or Impeding Progress?” David presented data detailing the current size and scope of the illicit market for e-vapor and pouch products in the U.S.

David also shared his perspective that restoring order to the market will require both FDA accelerating its review and authorization of smoke-free products and more enforcement activity at the federal and state levels to clean up the illicit market.