BAT to Launch New Disposable Vape in US Despite No FDA Approval
After years of fighting against the sale of unauthorized disposable e-cigarettes in the United States, British American Tobacco (BAT) is preparing a strategic U-turn. The tobacco giant plans to test-launch its first new disposable vape product, the Vuse One, in the U.S. market, despite not yet having received a marketing license from the Food and Drug Administration (FDA). This move comes as the company acknowledges that the flood of unregulated competitor products has severely impacted its own sales in the world’s largest market for smoking alternatives.
Luis Pinto, a spokesperson for BAT’s U.S. subsidiary Reynolds American, told Reuters that the “lack of access to this market is negatively affecting our bottom line.” The Vuse One, which uses lab-made synthetic nicotine, is currently awaiting FDA authorization. Pinto revealed that pilot sales are slated to begin in late September or early October in South Carolina, Florida, and Georgia.
This strategy, however, is drawing sharp criticism. The FDA, which regulates nicotine products, stated that entering the market without a license violates the law. “All new tobacco products… that are on the U.S. market without the statutorily required FDA authorization are marketed unlawfully,” the agency told Reuters. While not commenting specifically on BAT’s strategy, the FDA emphasized that a pending application does not create a “legal safe harbor for the sale of a product.”
Brian King, vice president for U.S. tobacco control programs at the Campaign for Tobacco-Free Kids and former head of the FDA’s Center for Tobacco Products, called BAT’s strategy illegal and dangerous. “Flooding the market with unapproved tobacco products… poses a risk to public health,” he said.
Pinto defended BAT’s approach, arguing it is different from that of illicit competitors. He stated BAT’s products undergo careful review, are sold through major national retailers, and adhere to stricter guidelines on product features and marketing. “This is not a case of: if you can’t beat them, join them,” he said.
The move represents a remarkable reversal for BAT and other major tobacco companies like Altria, which have previously lobbied against and filed complaints about unauthorized synthetic nicotine products. In 2023, Reynolds wrote to the FDA complaining that such products were on the market illegally and harming legitimate businesses. Now, both companies have signaled a change in stance, with Altria’s CEO William Gifford telling investors in April that they are “exploring all available options” to enter this space.
The backdrop to this shift is the FDA’s slow pace in processing a massive number of pre-market tobacco applications (PMTAs). While large tobacco companies have waited for approvals, a booming market for unregulated disposables, often from Chinese manufacturers with youth-appealing flavors and high nicotine doses, has exploded. BAT estimates the U.S. disposable vape market reached $8 billion last year, accounting for about 70% of the entire industry’s revenue. With its own U.S. e-cigarette sales declining, BAT appears to be operating at the edge of what it believes regulation will permit, a move one investor described as acting “absolutely at the limit of what regulation allows.”
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