FDA to Review IQOS Modified Risk Status

The U.S. Food and Drug Administration will convene its Tobacco Products Scientific Advisory Committee on October 7 to assess whether Philip Morris International’s heated tobacco device IQOS should retain its Modified Risk Tobacco Product (MRTP) status.

IQOS first received MRTP authorisation in 2020, allowing PMI to market it as a less harmful alternative to cigarettes based on reduced exposure to toxicants. The upcoming review will consider updated scientific data, including switching studies and biomarker evidence.

PMI argues IQOS remains a critical harm reduction tool, producing significantly lower levels of harmful chemicals than combustible tobacco. Supporters say maintaining MRTP status will encourage smokers to switch, while critics caution about dual use and long-term uncertainty.

The hearing will be closely watched by both the industry and public health community. If IQOS retains its designation, it could strengthen the case for heated tobacco as part of a wider harm reduction strategy. If not, it may signal a tougher regulatory climate for alternative nicotine products in the U.S.

Whatever the outcome, the review reflects the central role of evidence-based decision-making in shaping the future of tobacco control. For smokers looking for alternatives, the FDA’s ruling could influence not just IQOS, but the broader landscape of reduced-risk products.

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