How FDA Can Better Align Its Draft Guidance on Flavored ENDS with the Tobacco Control Act’s APPH Mandate

As discussed in our earlier post, the U.S. Food and Drug Administration’s (FDA) new draft guidance on flavored electronic nicotine delivery system (ENDS) products represents a meaningful effort to provide additional clarity about the Agency’s evidentiary expectations for premarket tobacco product applications (PMTAs). That clarity is welcome. At the same time, the draft guidance would... Continue Reading