Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability

Resumen

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications--Considerations Related to Youth Risk; Draft Guidance for Industry." The draft document describes FDA's current thinking and provides recommendations regarding evidentiary considerations for premarket tobacco product applications (PMTAs) for flavored ENDS submitted under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).