CERSI P.I.: Sarah Michel, Ph.D, UMB School of Pharmacy
FDA SME and Collaborators: Vyomesh Patel, Ph.D., CTP
Regulatory Science Challenge
Researchers will also analyze ENDS hardware, e-liquids (including color and ingredients), and the constituents of the complex aerosol for each ENDS category evaluated. All data collected will be compiled into a database that may help to inform the regulatory decision-making process. Project findings may inform future regulatory activities related to ENDS.
Project Description and Goals
Study aims are: (1) to determine the effects of ENDS aerosol on cells of the oral cavity and upper respiratory tract, and (2) to identify the constituents of e-liquids, hardware and aerosol to which ENDS users are exposed. In this study, five pre-filled ENDS and two cartomizers and their associated e-liquid formulations will be aerosolized and effects on cells will be assessed (via proteomics and in vitro cell biology assays of specific biological pathways by immunoblotting, cytokine quantitation and metallomics) against appropriate controls.
Learn more on the U.S. Food and Drug Administration website