Philip Morris International on Tuesday won federal clearance to sell its tobacco heating device IQOS, a decision that comes as the Food and Drug Administration continues to balance encouraging healthier nicotine alternatives with decreasing youth usage of methods like e-cigarettes.
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In approving the product, the agency said it produces “fewer or lower levels of some toxins than combustible cigarettes.”
The FDA is still weighing a separate application from the New York City-based company on whether the IQOS, which works by heating tobacco rather than burning it, is safer than combustible cigarettes.
“While the authorization of new tobacco products doesn’t mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health,” director of tobacco products Mitch Zeller said in a statement, adding that the FDA will monitor how it is marketed and youth usage of the product.
Altria, which owns Philip Morris USA and is selling the product in the country through a license deal with Philip Morris International, intends to "test a range of marketing, sales and consumer engagement approaches" to raise awareness of the product, "all while taking steps to minimize reach to unintended audiences, consistent with the FDA order and marketing requirements," it said in a statement.
Sales will begin Atlanta, Georgia and Altria expects to scale distribution quickly.
Alongside the impact on younger populations, the FDA also reviewed whether IQOS would help existing tobacco users cut down on smoking. The product contains lower levels of chemicals like formaldehyde and acrolein when compared to combustible cigarettes with similar amounts of nicotine, suggesting that users could transition away completely and only use the IQOS.
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Tobacco companies like Philip Morris, which is owned by Altria, are turning to products like the IQOS and Juul as a way to bolster profits as smoking levels reach historic lows. Despite those declines, youth use of electronic cigarettes has grown, prompting the FDA to take new actions against tobacco retailers and amplifying public pressure on Juul and others.
Critics say the devices are not a healthier alternative and are ploys to get new customers, including younger generations, addicted to nicotine.
While former FDA Commissioner Scott Gottlieb advanced many of the agency’s existing efforts, acting commissioner Ned Sharpless has said he will continue work on the initiatives of his predecessor.