Philip Morris Seeks FDA Approval To Keep IQOS Modified Risk Designation For Later Versions Of Device

Philip Morris International Inc. (PM) said on Wednesday that its experts met with the Tobacco Products Scientific Advisory Committee on October 7 as it seeks to continue marketing versions of its IQOS heated tobacco products in the U.S. as modified risk tobacco products.

The committee provides nonbinding recommendations to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). The modified risk tobacco product designation granted by the FDA initially in 2020 allowed the company to advertise its perks, including that the IQOS system heats tobacco instead of burning it, significantly reducing the production of and users’ exposure to harmful chemicals.

PMI has requested that it be allowed to continue marketing versions of IQOS as modified risk tobacco products.

“We encourage the FDA to continue efforts to establish a timely scientific review process for smoke-free products—including for IQOS ILUMA, which has been pending FDA review for nearly two years and has globally shown even higher rates of legal-age adults fully switching from combustible cigarettes—that are a better choice for legal-age adults who would otherwise use traditional tobacco products, including combustible cigarettes,” PMI U.S. CEO Stacey Kennedy said.

The company estimates that there are approximately 34 million IQOS consumers globally who have moved away from cigarettes or significantly reduced their consumption as of June 30. PMI first entered the U.S. market in 2022, following its acquisition of Swedish Match.

On Stocktwits, retail sentiment around PM stock fell from 'extremely bullish' to 'bullish' territory over the past 24 hours, while message volume stayed at 'high' levels. 

PM stock is up by 28% this year and by 30% over the past 12 months. 

Read also: Ford Faces Up To $1 Billion Hit After New York Aluminum Plant Fire, Analysts Reportedly Say

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