FDA’s New ENDS and Nicotine Pouch Enforcement Guidance: Lower Priority for Post-November 2021 Reviewable Applications, Higher Scrutiny for Illicit Products

On May 8, 2026, the U.S. Food and Drug Administration (FDA) issued final guidance describing how the Agency intends to prioritize enforcement for certain unauthorized electronic nicotine delivery systems (ENDS) and oral nicotine pouch products marketed without premarket authorization. The guidance is effective immediately and replaces FDA’s prior April 2020 ENDS enforcement-priorities guidance. Critically, the... Continue Reading