Spotlight: FDA’s Current Approach to Toxicological Risk Evaluation to Inform APPH: A Nonclinical Case Study of Breeze Pro Disposable ENDS

In 2024, the FDA released two key scientific memoranda that shifted their approach to evaluating toxicological risk in ENDS PMTA from a mixture-based to a component-based framework, focusing on individual constituents and their cancer risk profiles. These memoranda established Quantitative Risk Assessment (QRA) as the cornerstone of toxicological risk evaluation in ENDS PMTAs, informing regulatory decisions on whether products are APPH. This presentation will explore the implications of the FDA’s new perspective, discuss strategies for navigating the evolving PMTA regulatory landscape, and use Breeze Pro ENDS chemistry, toxicology, and QRA as a case study.