FDA Authorizes the Sale of IQOS 3 Tobacco Heating System Device in U.S.

FDA Authorizes the Sale of IQOS 3 Tobacco Heating System Device in U.S.

Altria Group, Inc. has announced that the U.S. Food and Drug Administration (FDA) has given it the authorization to begin selling the IQOS 3 tobacco heating system device in the U.S.

This follows the review of Philip Morris International’s (PMI) submission of a Premarket Tobacco Product Application (PTMA) to the FDA for IQOS 3. To gain market authorization through the PMTA process, Philip Morris USA had to demonstrate that its marketing of IQOS 3 was appropriate for the “protection of public health” and required the FDA to consider the risks and benefits to the U.S. population as a whole, including those who will use the product and non-tobacco users. Unlike traditional cigarettes, IQOS heats–but does not burn–tobacco. IQOS 3 offers several enhancements and improvements over the previous heat not burn system IQOS 2.4, including a longer battery life, faster recharging, a side opening mechanism and magnetic closure. PMI submitted a supplemental PMTA to the FDA for the IQOS 3 back on March 30, 2020. Previously, the FDA authorized IQOS 2.4 to be sold in the U.S. back on April 30, 2019. On July 7, 2020, the FDA authorized IQOS 2.4 to be marketed using a modified risk tobacco product with reduced exposure claim.

In a press release, Philip Morris USA president and CEO Jon Moore commented: “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.”