PMI Submits Applications for Iqos Iluma

Heat-not-burn tobacco product already sold internationally
Photograph courtesy of Philip Morris International

Philip Morris International has submitted premarket and modified risk tobacco product (MRTP) applications for its Iqos Iluma heated tobacco products.

The applications, if authorized by the Food and Drug Administration, would allow Iqos Iluma to be sold in the United States and be marketed as a modified risk product that reduces exposure to harmful and potentially harmful chemicals.

“Tens of millions of American adults today smoke cigarettes and will likely continue to do so,” said Stacey Kennedy, president of Americas and CEO of PMI U.S. Business. “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. 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 U.S. and drive a rapid decrease in smoking rates among adults. These are strong applications, and we urge the FDA to prioritize them for review.”

Iqos products heat—but do not burn—tobacco. They deliver substantially similar reductions in the formation of harmful and potentially harmful constituents as earlier versions of Iqos products, the company said. Iqos Iluma products are already in 27 markets internationally, and the product has demonstrated higher rates of full switching by adults using cigarettes, PMI said.

The Iqos Iluma devices operate on a Smartcor Induction System that heats tobacco from within Terea Smartcor Sticks, heated tobacco sticks designed to be used only with Iqos Iluma devices. PMI submitted applications for three Iluma devices and five variants of the tobacco sticks: Terea Blue, Terea Green, Terea Sienna, Terea Bronze and Terea Amber.

The applications were submitted by PMI Friday, but it could be years before the product potentially hits the U.S. market. The FDA is still reviewing premarket tobacco product applications (PMTAs) that were turned in before a Sept. 9, 2020, deadline. It expects to be finished reviewing the major e-cigarette players’ applications by the end of the year.

Other versions of Iqos have already received MRTP designation. The product hasn’t been sold in the country for over a year, however, due to a U.S. International Trade Commission (ITC) ruling that said the product infringes on two patents held by rival R.J. Reynolds, Winston-Salem, North Carolina. The ruling only pertains to imported product, PMI said. The company has plans to commercialize other versions of Iqos in the U.S. in select cities in second quarter 2024.

Altria, Richmond, Virginia, was previously authorized to sell Iqos in the United States under an agreement with PMI, New York. However, in October 2022 the companies announced the agreement would end, giving PMI full U.S. commercialization rights to Iqos starting in April 2024.

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