FDA authorizes sale of Altria’s IQOS 3 device

System heats tobacco instead of burning it

Published December 7, 2020 by Kate Andrews

The third generation of Altria Group Inc.’s IQOS tobacco heating system device has been authorized for sale in the United States by the U.S. Food and Drug Administration, the Henrico County-based company announced Monday.

After receiving an application from Philip Morris International, the FDA ruled that IQOS 3 can be sold to adults in the U.S. market. IQOS, which was launched in the United States last year through an exclusive license with Philip Morris USA and Altria, uses tobacco-filled Marlboro HeatSticks that are heated but not burned. It is available in Richmond and the Atlanta and Charlotte, North Carolina, markets. The FDA review says that IQOS 3 has a similar design to its predecessors and that its nicotine exposure, abuse liability, use patterns and user populations are virtually the same as the two previous versions.

Altria markets IQOS as a way for adult smokers to transition from combustible cigarettes to noncombustible smoking devices. HeatSticks are required by law to come in menthol and tobacco flavors only so as not to be attractive to underage users. The IQOS 3 device offers longer battery life, faster recharging and magnetic closure, according to Altria.

In July, the FDA ruled that the IQOS 2.4 system was allowed to be marketed as a “modified risk” product, a safer alternative to cigarettes. Philip Morris will have to file a second application with the FDA seeking authorization of a reduced exposure claim for IQOS 3, which it plans to do, according to the company.

A longtime Fortune 500 company listed among the S&P 500, Altria is the parent company of Richmond-based tobacco products manufacturer Philip Morris USA, best known for its Marlboro cigarettes brand.

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