FDA authorized flavored e-cigarettes without required public-comment period, bypassing its own career staff

On May 5, 2026, the FDA finalized enforcement-discretion guidance and authorized four flavored Glas e-cigarette products, skipping the legally required draft-guidance and public-comment period. FDA career staff were not consulted and learned of the change the night before publication; former FDA Tobacco Center director Mitch Zeller and other officials said the move blindsided the agency's own regulatory staff.

The action followed a $5 million donation from a Reynolds American subsidiary to the pro-Trump super PAC MAGA Inc. on April 30, 2026, a May 2, 2026 lunch meeting between President Trump and Reynolds executives and lobbyists at which FDA vaping regulation was reportedly discussed, and reported calls from Trump to FDA Commissioner Marty Makary and HHS officials about e-cigarette regulation. Makary resigned the week after the guidance posted. The New York Times' investigation documented the donation, the lunch, and the reported calls, but stated it found no definitive evidence directly linking the guidance to the donation or lobbying, and noted Makary had resisted flavored-vape authorization for months before resigning. The archive-fit basis for this entry is the independently confirmed procedural violation — the skipped public-comment period, reported by AP and STAT News and confirmed by named former FDA officials — not the unproven donation-causation theory.

Updates

2026-05-11 -- 21 state attorneys general petitioned FDA to reverse the guidance [6]

A bipartisan coalition of 21 state attorneys general, led by Connecticut Attorney General William Tong, formally petitioned the FDA to reverse the guidance authorizing the flavored e-cigarette products.

2026-05-12 — FDA Commissioner Makary resigned after weeks of conflict with the administration over the flavored-vape decision; Kyle Diamantas named acting commissioner [7, 8, 9]

FDA Commissioner Marty Makary resigned on May 12, 2026, after what multiple outlets described as weeks of conflict with the Trump administration; the flavored-vape guidance above was reported as "the final straw," with Makary having told confidants his conscience would not let him approve products with youth appeal. President Trump had personally pressed Makary over the FDA's initial refusal to approve the products before the agency reversed course. The Washington Post reported that administration officials had already approved plans to replace him in the days before he stepped down. Kyle Diamantas, then FDA deputy commissioner for food, was named acting commissioner.