Altria Group, Inc. has revealed that it has received authorization from the U.S. Food and Drug Administration (FDA) to sell its heat-not-burn device, IQOS, in the U.S. market. The FDA authorization follows IQOS’ premarket tobacco product application (PMTA) that was submitted by Philip Morris International, Inc. (PMI). Philip Morris USA (PM USA) has an exclusive licensing agreement with PMI, which will commercialize IQOS in the U.S. with three HeatStick variants.
PMI submitted a Modified Risk Tobacco Product (MRTP) application for IQOS on Dec. 5, 2016. This application was an important first step in getting FDA authorization to be able to market the product in the U.S. with modified risk claims. Scientific review of the MRTP application is ongoing and independent of the PMTA marketing order authorization. For PM USA to secure market authorization under a PMTA, the company had to demonstrate that marketing IQOS as appropriate for the protection of public health and required the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
“With FDA authorization, PM USA will introduce IQOS in the U.S. for adult smokers in Atlanta, Georgia to learn as much as possible, as quickly as possible, and intends to make the most of the company’s first-mover advantage in heated tobacco,” said Howard Willard, Chairman and Chief Executive Officer of Altria. “IQOS has had terrific success internationally. We’re very excited to bring this platform to adult smokers in the U.S.”
IQOS offers an innovative alternative for adult smokers who are seeking an alternative to traditional combustible cigarettes. While IQOS will be new to the U.S. market, it is already being sold in international markets. PMI reports that currently more than seven million people globally have fully switched to IQOS.
PM USA already has plans and a strategy for rolling out the new heat not burn device in the U.S. market. The company has plans to have a number of retail touchpoint in Atlanta, including an IQOS store that will be located within Lenox Square. Numerous mobile retail units and HeatStick distribution in approximately 500 retail trade partner stores including Circle K, Murphy USA, QuikTrip, RaceTrac, Speedway and select additional retail partners. With this new authorization, PM USA has plans to scale IQOS “quickly and efficiently,” according to the company in its press release.
Altria has been making numerous investments in harm reduction, as it is identified as a major product category as tobacco sales and use among consumers continues to decline. As part of Altria, PM USA will use IQOS to continue the company’s efforts to build its smoking cessation and cigarette alternative portfolio and has set a goal to convert as many U.S. adult smokers who are interested in non-combustible alternatives to IQOS users.
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