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The U.S. Food and Drug Administration (FDA) has authorized the renewal of MRTP orders previously granted to Philip Morris International (PMI) for two IQOS device versions and three HEETS consumables. The renewal allows PMI to continue sharing reduced-exposure information with U.S. adults aged 21 and older who use traditional tobacco products.
The FDA said it concluded that renewing the MRTP authorizations for IQOS and HEETS is appropriate to promote public health and may benefit the health of the population as a whole. The agency also reaffirmed that the available evidence indicates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely.
PMI said the decision reflects what it describes as a rigorous scientific foundation and its ongoing commitment to responsibly deliver smoke-free choices to adult consumers.
The renewed authorization covers the following:
PMI said the IQOS 2.4 system was the first heated tobacco product authorized via MRTP in 2020, and the IQOS 3 system received MRTP authorization in 2022.
PMI noted that its MRTP submission includes scientific evidence indicating that aerosol contains substantially lower levels of harmful and potentially harmful constituents than cigarette smoke.
PMI U.S. said it is focused on offering better options to about 45 million legal-age nicotine consumers in the United States, including roughly 25 million who still smoke.
PMI also stated that since 2008 it has invested more than $16 billion globally to develop smoke-free products. PMI entered the U.S. market in 2022 after acquiring Swedish Match, aiming to move adults away from cigarettes toward scientifically substantiated smoke-free products.
The company included a forward-looking statements disclaimer noting that future results depend on risks and uncertainties, and that it does not undertake to update forward-looking statements except as required.
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