The U.S. Food and Drug Administration has slated a meeting of its Tobacco Products Scientific Advisory Committee (TPSAC) for October 7, 2025, to evaluate the renewal applications for Philip Morris Products S.A.’s modified-risk status on several IQOS products. The review will cover five products: Marlboro Amber HeatSticks, Marlboro Green Menthol HeatSticks, Marlboro Blue Menthol HeatSticks, the IQOS 2.4 system holder and charger, and the IQOS 3.0 system holder and charger. These products were originally authorized under modified-risk orders in 2020 and 2022, using claims of reduced exposure to harmful chemicals, not reduced risk of disease. The upcoming meeting will assess whether the scientific standards continue to be met under the provisions of the Family Smoking Prevention and Tobacco Control Act.
The original approvals allowed claims that switching completely from cigarettes to IQOS significantly reduces exposure to harmful and potentially harmful chemicals without asserting reduced risk of disease or safety. The FDA required postmarket surveillance, annual reporting, and a limited lifecycle for each MRTP order. Renewal applications have now been submitted to ensure compliance continues beyond the original expiry periods.
The TPSAC review will take place at FDA’s White Oak Campus in Silver Spring, MD, and is open to the public both in-person and via webcast. Stakeholders, from industry participants to public health advocates, may provide oral testimony between 1:00–2:00 p.m. ET, with written comments accepted through September 25, 2025. Requests to speak must be submitted by September 11, 2025, along with a summary of the intended presentation. The federal register notice confirms that meeting materials will be posted ahead of time and background documents may appear online up to two business days before.
TPSAC’s recommendations to FDA will focus on whether the products continue to meet statutory criteria: significant reduction in exposure, potential impact on tobacco initiation and cessation, youth uptake, and overall population health considerations. While TPSAC’s opinion is non-binding, its analysis is a key input for FDA’s final determination. New data from postmarket studies and annual reports, which were updated and posted online as of July 29, 2025, will inform the scientific discourse.
