LONDON, April 1, 2026, 13:10 BST
British American Tobacco’s push to widen sales of its Velo nicotine pouches in the United States has run into a regulatory delay. Reuters reported on Wednesday that the U.S. Food and Drug Administration had yet to clear several products in a fast-track review scheme that had been expected to deliver decisions by the end of 2025, leaving BAT’s pending applications still unresolved. 1
The timing matters for BAT. The group is leaning on smoke-free products — nicotine pouches, vapes and heated-tobacco devices — to cushion the long decline in cigarette volumes, and in February said 2026 performance was likely to land at the lower end of its medium-term growth ranges even after 2025 came in at the top end of guidance. 2
BAT has put the U.S. at the centre of that plan. In prepared remarks for a February investor conference, Chief Executive Tadeu Marroco called the market the “cornerstone” of BAT’s strategy, while Reynolds American, its U.S. arm, said Velo Plus ended 2025 with 24% volume share nationally and about 5 million adult nicotine consumers. 3
The FDA launched its nicotine pouch pilot in September to speed premarket tobacco product applications, or PMTAs, the filings required before new tobacco products can be sold legally in the U.S. The agency said the pilot was meant to streamline reviews while keeping its scientific standards intact. 4
In December, the FDA cleared six Altria-linked on! PLUS pouches, the first decisions under the scheme. Acting tobacco chief Bret Koplow said then that “rigorous and efficient standards of scientific review are not mutually exclusive,” while BAT said this week its own applications merited authorisation and that it was still engaging with the agency. 5
That leaves BAT chasing a market still led by Philip Morris International’s Zyn. Marroco told analysts in February he was “extremely encouraged” by Velo’s U.S. performance, and BAT’s investor materials described Velo as the fastest-growing brand in the fastest-growing nicotine pouch category. 6
BAT’s latest numbers show why the company is pressing so hard. New-category revenue — BAT’s term for pouches, vapes and heated tobacco — rose 7% at constant currency in 2025 to 3.621 billion pounds, or 18.2% of group revenue, and Marroco said Velo Plus had delivered “excellent results” in the U.S. with triple-digit growth. 2
Still, the overhang has not gone away. Reuters reported FDA scientists had hesitated over some pending pouch applications because of worries about addiction risks for youth and other new users, although the agency said the pilot cases were still on track for faster decisions than most reviews; BAT, separately, warned that illicit vapes in the U.S. and fiscal and regulatory pressure in Australia and Bangladesh would keep 2026 growth weighted to the second half. 1
For BAT, the downside is plain enough. A slower or more restrictive FDA path would leave Velo with less room to expand legally and make BAT’s shift toward smoke-free products harder to pull off, even as the company sticks with a 1.3 billion pounds buyback for 2026 and still expects leverage to fall into its target range by year-end. 1
