U.S. FDA to Review Philip Morris International’s IQOS Risk Modification Renewal Application in October

Key points:

·Key Event: The US FDA will hold a TPSAC meeting on October 7th to discuss the renewal application for the IQOS product's "reduced risk" designation. 

·Products involved include Marlboro Amber, Green Mint, Blue Mint heat-not-burn pods, as well as the IQOS 2.4 and 3.0 systems and chargers. 

·Evaluation Focus: The meeting will focus on scientific evidence to determine whether the products continue to meet the "reduced risk" standard. 

·Public Participation: The meeting is open to the public and can be watched via live stream online. The public can submit written comments or apply to speak.

【2Firsts News Flash】According to an announcement on the FDA's official website on July 29th, the U.S. Food and Drug Administration (FDA) has issued a Federal Register notice declaring that the Tobacco Products Scientific Advisory Committee (TPSAC) meeting is scheduled to be held on October 7, 2025. The meeting will discuss the renewal of the "Modified Risk Authorization" for products from Philip Morris International (PMI) (Philip Morris Products S.A.).

·Marlboro Amber HeatSticks

·Marlboro Green Menthol HeatSticks

·Marlboro Blue Menthol HeatSticks 

·The IQOS system includes the IQOS 2.4 main unit and charger, as well as the IQOS 3.0 main unit and charger.

The FDA initially authorized the sale of these products through the Pre-Market Tobacco Product Application (PMTA) pathway in 2019 and 2020. Subsequently, in 2020 and 2022, the FDA issued "modified risk orders," allowing Philip Morris International (PMI) to market these five IQOS heated tobacco products as "reduced risk tobacco products" based on information that they reduce exposure to harmful substances.

Based on the current available evidence:

·The IQOS system heats tobacco without burning it, significantly reducing the production of harmful and potentially harmful chemicals. 

·Scientific research shows that switching completely from traditional cigarettes to the IQOS system can significantly reduce the body's exposure to harmful or potentially harmful chemicals.

After evaluating the scientific evidence provided by applicants, the FDA issued "risk reduction orders" to ensure that information about reducing exposure risks is supported by scientific evidence and easily understandable to consumers. These "risk reduction orders" require companies to conduct post-market surveillance and studies to determine if the authorization for "reduced risk tobacco products" should continue. According to the law, the validity of these orders is fixed as stipulated in the authorization and not permanent.

In order to continue marketing these products as "reduced risk tobacco products" after the authorization period expires, the company submitted a renewal application to the FDA. On May 9, 2024, the FDA conducted a scientific review of these applications and made the application materials available online for public comment. According to the law, the FDA must disclose the application materials to the public and submit the applications to TPSAC. The discussion at the TPSAC meeting will focus on whether the scientific standards for marketing these products as "reduced risk tobacco products" continue to be met.

The TPSAC meeting will be open to the public and held at the White Oak campus of the FDA in Silver Spring, Maryland. Additionally, the public can watch the meeting via live webcast with subtitles and recordings available. Visit the event page for more information on attending in person or online.

Stakeholders can provide data, information, or opinions on issues under consideration by the committee in oral or written form. Written comments must be submitted to the contacts listed in the Federal Register notice by September 25, 2025. Public oral comments will be scheduled for October 7, 2025, from 1:00 to 2:00 PM (Eastern Time). Those wishing to make oral comments must notify the contacts by September 11, 2025, and provide a brief statement describing the nature of the evidence or arguments they wish to present, the names and email addresses of anticipated participants, and whether they prefer to speak online or in person. For more information, please refer to the Federal Register notice.

Furthermore, the FDA has reissued application documents related to the renewal of the existing authorization for the IQOS product as a "reduced risk tobacco product." These reissued documents include information that was previously redacted. The application materials that were redacted in accordance with applicable laws and regulations can be found on the FDA website. The FDA will consider all available information, including public comments and recommendations from TPSAC, before making a final decision on the application for the "reduced risk tobacco product.