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Advisory Committee Meeting Scheduled on Modified Risk Tobacco Product Renewal Applications for IQOS Products

FDA has issued a Federal Register notice announcing a Tobacco Products Scientific Advisory Committee (TPSAC) meeting on October 7, 2025, to discuss the renewal of modified risk granted orders issued to Philip Morris Products S.A. for the following products: 

  • Marlboro Amber HeatSticks  
  • Marlboro Green Menthol HeatSticks  
  • Marlboro Blue Menthol HeatSticks 
  • IQOS 2.4 System Holder and Charger 
  • IQOS 3.0 System Holder and Charger

FDA initially authorized these products for sale via the Premarket Tobacco Product Application (PMTA) pathway in 2019 and 2020. Then in 2020 and 2022, FDA issued modified risk granted orders authorizing Philip Morris Products S.A. to market these five IQOS heated tobacco products with the following reduced exposure information:

“AVAILABLE EVIDENCE TO DATE:

  • The IQOS system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

FDA issued the modified risk granted orders after evaluating the scientific evidence provided by the applicant, ensuring that the information directed at consumers about the reduced exposure was supported by scientific evidence and is understandable. The modified risk granted orders required the company to conduct postmarket surveillance and studies to determine whether the MRTP orders continue to be appropriate. By law, the orders are valid for a fixed time period, as specified in the orders, and are not permanent.

To continue marketing the products as modified risk products after the authorized term, the company submitted MRTP renewal applications to FDA. On May 9, 2024, FDA filed these applications for scientific review and posted application materials online for public comment. By law, FDA must make the application materials available to the public and refer the applications to TPSAC. The TPSAC meeting’s discussion will focus on whether the scientific standards continue to be met to market the products as modified risk tobacco products.

The TPSAC meeting will be open to the public and held at FDA’s White Oak Campus in Silver Spring, MD. Additionally, the public can attend via webcast, and it will be captioned and recorded. Please visit the event page to learn more about attending in person or online.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be submitted to the contact person listed in the Federal Register notice on or before September 25, 2025. Oral presentations from the public will be scheduled between 1:00 p.m. and 2:00 p.m. ET on October 7, 2025. Those interested in making oral presentations should notify the contact person and submit a brief statement describing the general nature of the evidence or arguments they wish to present, the names and email addresses of proposed participants, and whether they would like to present online or in-person on or before September 11, 2025. Review the Federal Register notice for more information.

Additionally, FDA reposted application documents related to the renewal of the existing MRTP orders for IQOS products. These reposted documents contain information that was previously redacted. The application materials, redacted in accordance with applicable laws and regulations, can be found on FDA’s website. Before making a final determination on an MRTP application, FDA takes into consideration all information available to the agency, including public comments and recommendations from the TPSAC. 
 

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