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FDA Authorizes Sale of the IQOS 3 Tobacco Heating System

FDA Authorizes Sale of the IQOS 3 Tobacco Heating System

RICHMOND, Va.--(BUSINESS WIRE)-- Altria Group, Inc. (Altria) (NYSE: MO) announces today that the U.S. Food and Drug Administration (FDA) authorized commercialization of the next generation of the IQOS tobacco heating system device, IQOS 3, in the U.S. 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 U.S. with three HeatStick variants. Unlike cigarettes, the IQOS system heats but does not burn tobacco.To get more news about Hitaste, you can visit official website.

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 magnetic closure.

“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 Chief Executive Officer of PM USA.

IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina 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.

To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.On July 7, 2020 the FDA authorized the marketing of the IQOS 2.4 tobacco heating system as a modified risk tobacco product with a reduced exposure claim. IQOS 2.4 is the first next-generation inhalable tobacco product to be authorized as a modified risk tobacco product. The IQOS 3 PMTA authorization is independent of the MRTP authorization for the IQOS 2.4 device. PMI expects to file a MRTP application with the FDA for IQOS 3 seeking authorization of a reduced exposure claim.
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