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The US Food and Drug Administration (FDA) confirmed that IQOS, Philip Morris International's electrically heated tobacco system, is appropriate for the protection of public health and has authorised it for sale in the US.
The FDA's decision follows its comprehensive assessment of PMI's premarket tobacco product applications (PMTAs) filed with the Agency in 2017.
Unlike cigarettes, the IQOS system heats — but does not burn — tobacco. It is the first electrically heated tobacco product to qualify for sale in the US pursuant to the 2009 law that empowers FDA to regulate tobacco products, including through oversight of innovative products. Commenting on the FDA's announcement, Andre Calantzopoulos, PMI's CEO, said it is an important step forward for the approximately 40 million American men and women who smoke.
He estimates that in just two years, 7.3 million people around the world have abandoned cigarettes and switched completely to IQOS.
"The order sets out clear commercialisation guidelines, including marketing requirements, that maximise the opportunity for adults to switch from cigarettes, while minimising unintended use. We fully support this objective. FDA has set a high standard and we look forward to working with them to implement the order so that IQOS is reaching the right audience — current adult smokers," said Calantzopoulos.
PMI will bring IQOS to the US market through an exclusive license with Altria Group.
PMI submitted a comprehensive body of scientific evidence in support of the PMTAs and of the parallel applications for IQOS as a "Modified Risk Tobacco Product", which the FDA continues to review.
