FDA Grants PMTA Approval to Next-Generation IQOS Device

RICHMOND, Va. — Altria Group Inc. received the green light to market IQOS 3 in the United States.

On Dec. 7, the company announced that the Food and Drug Administration (FDA) authorized commercialization of the next generation of the IQOS tobacco heating system device. FDA authorization follows review of the IQOS 3 Premarket Tobacco Product Application (PMTA) submitted by Philip Morris International Inc. (PMI).

Philip Morris USA (PM USA), under an exclusive agreement with PMI, commercializes the IQOS system in the United States with three HeatStick variants.

According to Altria, IQOS 3 offers several enhancements to the IQOS 2.4 currently being sold in select U.S. markets, including a longer battery life, faster re-charging time, a side opening mechanism, and a magnetic closure.

The FDA authorized the IQOS 2.4 device for commercialization in the United States on April 30, 2019. On July 7, 2020, the agency authorized the marketing of the IQOS 2.4 tobacco heating system as a modified risk tobacco product with a reduced exposure claim. 

"Altria's 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we're excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets," said Jon Moore, president and CEO of PM USA.

IQOS is currently available in the Atlanta, Richmond and Charlotte, N.C., markets. With PMTA authorization of IQOS 3, PM USA expects to begin quickly marketing the IQOS 3 device to U.S. adult smokers once the regulatory and U.S. importation logistics have been satisfied.

Richmond-based Altria's wholly owned subsidiaries include PM USA, U.S. Smokeless Tobacco Co. LLC, John Middleton Co., Ste. Michelle Wine Estates Ltd., and Philip Morris Capital Corp. The company holds equity investments in Anheuser-Busch InBev SA/NV, Juul Labs Inc. and Cronos Group Inc.