British American Tobacco's E-Cigarette Vuse Gets FDA Authorization
Oct 13, 2021 1 min, 22 secs
Food and Drug Administration authorized British American Tobacco Plc’s e-cigarette Vuse and its tobacco-flavored pods, the first major e-cigarette products cleared in a sweeping review of whether millions of cigarette alternatives have a public-health benefit.

The agency denied BAT’s request to sell flavored Vuse products, saying those must be removed from the market.

“The manufacturer’s data 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.”.

The FDA’s decisions could make or break fortunes for cigarette companies, which are increasingly diversifying into alternatives like e-cigarettes and oral nicotine pouches, and for rival upstarts that make competing next-generation nicotine products.

At the same time, the FDA said, the data showed most of them had started with “flavors such as fruit, candy or mint, and not tobacco flavors,” and that this information in particular reinforced its decision to approve only the tobacco-flavored products.

The agency has already authorized a handful of products under its so-called PMTA process, or premarket tobacco product application: IQOS, a heat-not-burn device made by Philip Morris International Inc.

Marlboros, which has 35 applications for various flavors and nicotine strengths of On!, an oral tobacco product in which it has an 80% stake.

The lack of a decision on Vuse’s menthol products will leave companies and investors guessing how the FDA will act on menthol in cigarette alternatives, after the agency said earlier this year that it plans to ban it in cigarettes because it heightens addiction.

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