On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).
The document, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for Industry,” available here (Draft Guidance), reflects FDA doubling down on its heightened expectations for flavored ENDS PMTAs.