Reuters: BAT to Launch Synthetic Nicotine Vape Vuse One in U.S., Hitting Shelves in Three States from Late September

Key Points

• BAT shifts strategy: After years of opposing unauthorized disposable vapes in the U.S., British American Tobacco (BAT) is preparing to launch its own unlicensed product.
• FDA approval pending: BAT’s new Vuse One disposable vape uses synthetic nicotine and is awaiting FDA authorization, but pilot sales will begin in late September or early October.
• Market pressure: With U.S. disposable vape sales estimated at £6 billion ($8 billion) in 2023—70% of the vape industry—BAT and Altria argue they should not be disadvantaged while illicit players dominate.
• Public health concerns: Campaigners warn BAT’s move prioritizes profits over health, while the FDA stresses selling products without premarket authorization remains unlawful.
• Industry divide: Critics call BAT’s U-turn reckless, while some investors say it could boost revenues amid a crackdown on illegal imports.

British American Tobacco (BAT) is making a dramatic shift in its U.S. strategy, preparing to launch a new disposable vape despite lacking Food and Drug Administration (FDA) authorization. The move marks a reversal after years of lobbying against unlicensed vapes and challenging rivals in court.

BAT’s U.S. subsidiary, Reynolds American, will introduce its Vuse One disposable brand, which uses synthetic nicotine, with pilot sales beginning in South Carolina, Florida, and Georgia by late September or early October. A spokesperson confirmed that the product’s FDA application has been pending since 2022, well beyond the agency’s 180-day review window.

The decision comes as sales of unregulated disposable vapes—often imported from China—have surged, hitting an estimated £6 billion ($8 billion) last year and accounting for 70% of the U.S. vape market. BAT says it has lost 33 million units in sales, about 10% of its U.S. volumes, since 2022.

Public health authorities remain divided over vaping’s role. While advocates argue e-cigarettes can help smokers quit combustible cigarettes, critics point to youth-targeted flavors such as “rainbow bubblegum” and “cookie butter,” raising fears of a new generation of nicotine users. The FDA has warned that all products sold without premarket authorization are illegal, though enforcement has lagged amid a flood of applications.

Campaigners blasted BAT’s move. Brian King of the Campaign for Tobacco-Free Kids called the strategy “illegal and dangerous,” while trade body American Vapor Manufacturers accused BAT of “breathtaking audacity” for launching Vuse One after previously attacking competitors. Still, some investors see the move as pragmatic, with Abax Investments noting it could bolster revenues as U.S. regulators tighten control on unauthorized imports.

BAT insists its approach is different from illicit rivals, emphasizing stricter marketing policies, due diligence, and sales through major national retailers. “It’s not about, if you can’t beat them, join them,” said Reynolds spokesman Luis Pinto. But with FDA approval still pending, the company faces a high-stakes gamble at the center of one of the most contentious battles in global tobacco regulation.