FDA Authorizes Tobacco-Flavored Vuse E-Cigarette, Rejects Its Fruity Versions

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Reynolds ruling on American products prompts agency approach to some e-cigarette flavors that are popular among teens

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In an effort to curb youth vaping, the FDA last year temporarily halted the sale of sweet and fruit e-cigarette refill cartridges. Manufacturers were allowed to submit those products for agency’s permission to resume their sales.

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The FDA rejected five flavors Reynolds had presented under the Vousse Solo brand, the company said. The agency said it is still reviewing Vus Solo’s menthol refill pods. Before the federal flavor ban went into effect last year, the company sold Solo refills in flavors such as watermelon, tea, mint and berry. The FDA has yet to rule on the company’s most popular model, the Vuse Alto, or two other Vuse devices.

A Reynolds spokesperson said the authorization of Reynolds’ Vus Solo device is “a pivotal moment” for the company and reflects the company’s years of research aimed at ensuring that adults have “innovative and potential alternatives to traditional tobacco products.” have access to less harmful alternatives.” The company is studying the FDA’s analysis of the unapproved products, she said.

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The agency said its decision was informed by new federal data released in September that showed Vues is the second most popular brand among children and teens. According to the survey, about 11% of high-school students who smoked in the past 30 days said they used vos.

“The agency takes these data very seriously and considers the risk to youth when reviewing these products,” the FDA said.

The agency noted the survey findings that the most commonly used flavors among young people were fruit, candy and desserts, mint and menthol.

The FDA’s determinations on Reynolds’ four Vousse e-cigarette models are significant for parent company British American Tobacco plc, which is trying to expand its e-cigarette market share in the US. Reynolds is the number 2 e-cigarette manufacturer in the US. Stores tracked by Nielsen accounted for 28% of sales in retail stores in the 52 weeks ended September 25, according to a Goldman Sachs analysis.

Last year all US e-cigarette makers were required to remove their vaping products from the market or submit them for FDA review. The agency is weighing, among other things, the potential well-being of adult smokers switching to a safer alternative against the potential harm of young people becoming addicted to nicotine. It may authorize only those products which it considers “fit for the protection of public health”.

Data presented by Reynolds “demonstrate that its tobacco-flavored products may benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in their consumption of cigarette – harmful chemicals.” by reducing their risk for cancer,” said FDA Director Mitch Zeller. Center for Tobacco Products.

Some lawmakers and public-health groups have called on the FDA to permanently ban all sweet and fruit-containing vapor products. Other public-health experts have argued that such flavors may help convert adult cigarette smokers to vaping. Agency officials have said they would review each product individually, rather than issue comprehensive rules.

NJOY Holdings Inc., the No. 3 player, also submitted fruit flavored cartridges for FDA review to bring them back to market. Market leader, Juul Labs Inc. just deposited its tobacco- and menthol-flavored refill pods.

Youth vaping has declined significantly in the US as federal sanctions raised the legal purchase age for tobacco products to 21 and prohibited the sale of fruit-flavored e-cigarette cartridges.

Jennifer Maloney [email protected] . Feather

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