FDA opens door to rewriting its vape and pouch approval rules

The FDA said Monday it will consider replacing the 2021 rule that governs how new e-cigarettes, nicotine pouches and other tobacco products win permission to be sold, citing an illicit market and a federal lawsuit. That suit, filed Sept. 2 in Texas by Altria's vaping and pouch subsidiaries and a retailers' group, argues the rule keeps the agency from meeting Congress's 180-day review deadline. Reynolds units have asked to join. The FDA said it will keep reviewing applications meanwhile, and that any change will come with public input. It set no timeline.

The wall: Complaint unread; no public-health response on record; no timeline

Tier: Confirmed (FDA); Reported (suit)

Sources

• fda.gov/news-events/press-announcements/fda-intends-evaluate-changes-pmta-regulatory-framework
• rttnews.com/3688221/altria-units-sue-fda-over-pmta-rule-spotlighting-review-delays.aspx
• law360.com/texas/articles/2523258

health politics federal

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