The Food and Drug Administration on Tuesday authorized a tobacco-flavored e-cigarette made by tobacco giant Reynolds American Inc. and rejected several sweet or fruit-flavored refill cartridges the company wanted to bring back on the market.
The decision signals the hard line the agency is taking on sweet and fruity e-cigarette flavors in a broad review it is conducting to determine which vaping products may remain on the U.S. market. Reynolds’s Vuse Solo vaporizer and its tobacco-flavored refill cartridges are the first products to receive authorization as part of the review.
In an effort to curb youth vaping, the FDA last year temporarily halted the sale of sweet and fruity e-cigarette refill cartridges. Manufacturers were allowed to submit those products for the agency’s permission to resume their sales.
The FDA rejected five flavors Reynolds had submitted under the Vuse Solo brand, the company said. The agency said it is still reviewing Vuse Solo’s menthol refill pods. Before the federal flavor restrictions took effect last year, the company sold Solo refills in flavors such as melon, chai, mint and berry. The FDA hasn’t yet ruled on the company’s most popular model, Vuse Alto, or two other Vuse devices.
The authorization of Reynolds’s Vuse Solo device is “an important moment” for the company and reflects years of company research aimed at ensuring that adults “have access to innovative and potentially less harmful alternatives to traditional tobacco products,” a Reynolds spokeswoman said. The company is studying the FDA’s analysis of the rejected products, she said.
The agency said its decision was informed by new federal data released in September, showing that Vuse is the second-most-popular brand among children and teens. Some 11% of high-school students who had vaped in the past 30 days said they used Vuse, according to the survey.
“The agency takes these data very seriously and considered risks to youth when reviewing these products,” the FDA said.
The agency noted the survey’s findings that the most commonly used flavors among young people were fruit, candy and desserts, mint and menthol.
The FDA’s determinations on Reynolds’s four Vuse e-cigarette models are important for parent company British American Tobacco PLC, which has been trying to expand its e-cigarette market share in the U.S. Reynolds is the No. 2 e-cigarette maker in the U.S., with 28% of sales in retail stores in stores tracked by Nielsen in the 52 weeks ended Sept. 25, according to a Goldman Sachs analysis.
All U.S. e-cigarette manufacturers last year were required to take their vaping products off the market or submit them for FDA review. The agency is weighing, among other things, the potential good of adult smokers switching to a safer option against the potential harm of young people getting hooked on nicotine. It may authorize only products it deems “appropriate for the protection of public health.”
The data Reynolds submitted “demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
Some lawmakers and public-health groups have called on the FDA to permanently ban all sweet and fruity vaping products. Other public-health experts have argued that such flavors can help adult cigarette smokers switch to vaping. Agency officials have said they would review each product individually rather than issuing blanket rules.
NJOY Holdings Inc., the No. 3 player, also submitted fruit-flavored cartridges for FDA review in a bid to bring them back on the market. Juul Labs Inc., the market leader, submitted only its tobacco- and menthol-flavored refill pods.
Youth vaping has fallen significantly in the U.S. since federal restrictions raised the legal purchase age for tobacco products to 21 and barred the sale of fruity-flavored e-cigarette cartridges.
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