FDA announces draft guidance availability on flavored ENDS PMTA evaluations

Draft guidance published in Federal Register (91 Fed. Reg. 11,980, Docket No. FDA-2026-D-1817)

Public comment period opens

FDA authorizes four Glas G2 ENDS products — including Gold (mango) and Sapphire (blueberry), the first non-tobacco/non-menthol flavors authorized through PMTA. Authorization hinged on DAR technology.

FDA issues separate enforcement priorities guidance for unauthorized ENDS and nicotine pouch products

Comment period closes. Bipartisan coalition of 21 state attorneys general submits opposition letter urging FDA to abandon the draft guidance.

Draft guidance remains active. No final guidance publication date has been announced.