FDA Approves Tobacco-Flavored Vuse Alto E-Cigarettes: Details

After an extensive scientific review, the Food and Drug Administration (FDA) issued marketing granted orders to R.J. Reynolds Vapor Company, a subsidiary of British American Tobacco P.L.C. BTI, for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable.

While the FDA is authorizing the marketing of these tobacco products in the U.S., it does not mean these tobacco products are safe nor are they “FDA approved.”

Additionally, this action is not an authorization or indication of appropriateness to market these products as modified risk tobacco products.

FDA evaluates premarket tobacco product application (PMTAs) based on a public health standard that considers the risks and benefits of the product to the population as a whole.

After reviewing the company’s applications, FDA determined there was sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of public health.

The applicant showed that these tobacco-flavored products could benefit adults who smoke cigarettes sufficiently to outweigh the risks, including to youth.

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According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarettes.

Only 6.4% of these students reported using tobacco-flavored products. To further mitigate youth use, FDA has placed stringent marketing restrictions on the new products and will closely monitor their marketing practices.

However, these products have continued to be sold while the ruling is challenged in court, reported The Wall Street Journal.

The decision by the FDA comes after a previous ruling prohibiting Reynolds American to sell the brand’s menthol versions.

The FDA’s decisions on Vuse are part of a comprehensive federal review of the vaping industry, requiring all U.S. e-cigarette manufacturers to provide evidence that their products are less harmful than cigarettes and offer a public-health benefit by helping smokers switch to a safer option.

The report further noted that Vuse Alto products accounted for approximately 40% of U.S. e-cigarette sales in stores tracked by Nielsen IQ for the year ending June 15, with menthol flavors making up $1.5 billion of the total sales.

Tobacco flavors represented $479 million in sales. Reynolds American also markets Camel and Newport cigarettes and recently introduced a nicotine-free vaping brand called Sensa.

Price Action: BTI shares are trading higher by 0.15% at $33.09 in premarket at last check Friday.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Photo via Midjourney

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