This guidance provides sponsors with recommendations on the nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications.

This guidance focuses on novel chemicals of the drug product formulation, novel chemicals generated from any chemical of the drug product formulation by the delivery system (e.g., heat-generated chemicals), and novel impurities from the drug product formulation and delivery system. This guidance does not address nonclinical toxicity studies that may be requested by the Center for Devices and Radiological Health to support use of the delivery system (e.g., biocompatibility studies).