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PMI seeks market authorisation for IQOS Iluma in US

October 21, 2023


Philip Morris International (PMI) on Friday submitted Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs) for IQOS Iluma heated tobacco products with the US Food and Drug Administration (FDA).

PMTA marketing order is required to commercialise any new tobacco product in the US. The company is also seeking an order to market IQOS Iluma products as modified risk products that reduce exposure to harmful, and potentially harmful chemicals, a claim authorised for previous versions of IQOS.

IQOS Iluma products are PMI’s most-innovative heated tobacco products, relying on a fundamentally different heating technology from previous versions of IQOS products. They also contain several technological advancements including improved device and battery longevity

At the same time, the company said they deliver substantially similar reductions in the formation of harmful and potentially harmful constituents as earlier versions of IQOS products authorised by FDA.

PMI has submitted applications for three Iluma devices and five variants of the Terea tobacco sticks.

“Tens of millions of American adults today smoke cigarettes and will likely continue to do so. They should have a range of scientifically substantiated better alternative nicotine products to choose from, and PMI is committed to providing them with new choices,” Stacey Kennedy, president Americas and chief executive of PMI US Business, said.

“Internationally, IQOS Iluma products have demonstrated how ground-breaking consumer-centric innovation can lead more adults to stop smoking. We believe that same success can be replicated in the US and drive a rapid decrease in smoking rates among adults. These are strong applications, and we urge the FDA to prioritise them for review.”

Launched in the UK last month, IQOS Iluma products are currently available in 27 markets internationally.

PMI will have the full rights to commercialise all IQOS products in the US as of April 30, 2024, as it ended the commercial relationship with Altria Group covering IQOS in the US.

Previous versions of IQOS products have been authorised by the FDA both for sale in the US, and as modified risk tobacco products with “reduced exposure” claims

PMI has announced plans to commercialise these versions of IQOS in two US states in select key cities in the second quarter of next year.