By Timothy S. Donahue
Top Takeaways
- BAT halts a planned pilot for unauthorized Vuse One amid FDA warnings and rising enforcement.
- PMI backs away from talk of launching unlicensed Zyn variants as FDA tests a streamlined PMTA pathway.
- Big tobacco faces intensifying competition from Chinese-made disposables that dominate the unregulated U.S. market.
British American Tobacco has paused a planned pilot launch of its unauthorized Vuse One disposable vape in the United States, stepping back as the FDA increases scrutiny of manufacturers considering sales outside the agency’s premarket authorization system.
BAT’s Reynolds American unit confirmed the delay after laying the groundwork earlier this year for a limited release of Vuse One without a marketing order. The decision eliminates what would have been one of the most aggressive tests yet of how far major manufacturers might push into a U.S. market dominated by unauthorized, mostly China-made disposable vapes.
“The planned pilot launch of Vuse One in selected states has been postponed,” a Reynolds spokesperson told media outlets, adding that the company will continue focusing on its existing U.S. portfolio, including a nicotine pouch already sold without FDA authorization.
BAT’s reversal highlights the increasingly tough position large manufacturers face in a $22 billion U.S. nicotine alternatives market where unauthorized products influence consumer expectations on flavor, format, and speed to market. Although the FDA has approved only a small number of vapor and oral nicotine products through the premarket tobacco product application (PMTA) process, thousands of unauthorized disposable vapes remain widely available and have shifted retail market share towards the illicit products.
Philip Morris International (PMI), which announced in September that it was open to testing unlicensed variants of its Zyn brand, has since retracted that stance. CEO Jacek Olczak stated last week that PMI’s “plan A” is to comply with FDA regulations after the agency indicated it would speed up reviews through a new pilot program.
Altria, however, plans to proceed with a limited test of an updated On! nicotine pouch this fall, despite not having a marketing order. The product is already available online.
The FDA told media it is aware that some companies have explored launching new products without approval and said it “takes such matters seriously.”
In a previously unreported Sept. 17 letter, the agency warned Reynolds that selling unauthorized products is illegal and the agency asked for information about any Vuse One sales. Reynolds said its decision to delay the launch was made before receiving the letter.
Advocacy groups have also pushed back against the FDA’s streamlined nicotine pouch PMTA pilot. Six organizations, including the Campaign for Tobacco-Free Kids, warned the agency that early details indicate a departure from historically strict evaluations. Bret Koplow, acting director of the FDA’s Center for Tobacco Products, stated that the pilot maintains rigorous scientific review while boosting internal efficiency.
The episode highlights the industry’s biggest challenge: traditional manufacturers face slow, uncertain approval processes while competing with a vast array of unauthorized products outside FDA oversight.
BAT’s withdrawal, PMI’s caution, and Altria’s solo effort demonstrate how uneven the regulatory and commercial environment has become—and how closely the next phase of FDA enforcement will be observed across the nicotine industry.
