Key Points:
·Background of Authorization: The FDA has authorized the Philip Morris product company's IQOS product for market twice, allowing them to label it with statements related to "HNB, reducing exposure to harmful chemicals."
·Renewal Progress: On May 9, 2024, the FDA accepted the MRTP renewal application, involving the IQOS 2.4, 3.0 systems, and three renamed Marlboro heated pods, to review if the products meet the requirements of Section 911(g)(2) of the Federal Food, Drug, and Cosmetic Act.
·Upcoming Arrangements: On October 7, 2025, TPSAC will hold a public meeting to discuss the renewal application, and the FDA will announce the deadline for opinions collection.
·Material Inquiry: Users can subscribe to email alerts or regularly check the website for application materials. Philip Morris product company uploaded the latest materials on September 25, 2025.
2Firsts, September 26, 2025 - According to a statement on the official website of the United States Food and Drug Administration (FDA) on September 25, the FDA has released new materials related to a modified risk tobacco product (MRTP) renewal application submitted by Philip Morris Products S.A. for several IQOS heated tobacco products.
Previously, the FDA issued Modified Risk Tobacco Product Orders (MRTPs), allowing PMI company to sell the following products and enabling them to label them with the statement "reduced exposure.
·IQOS 2.4 device with charger and heating pod (approved on July 7, 2020)
·IQOS 3.0 device with charger (approved on March 11, 2022)
These products are authorized for sale in the market, but need to provide the following information to reduce exposure.
Evidence thus far:
·The IQOS system heats tobacco instead of burning it, which reduces 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 chances of the body being exposed to harmful or potentially harmful chemicals.
Information regarding the Modified Risk Tobacco Product (MRTP) application approval documents and decision summaries can be found on the "Modified Risk Orders" webpage.
On May 9, 2024, the FDA accepted an application for a "Modified Risk Tobacco Product (MRTP) Renewal" submitted by Philip Morris Products Company and will begin a scientific review.
·IQOS 2.4 device and charger
·IQOS 3.0 device and charger
·Marlboro Amber HeatStick (formerly known as "Marlboro HeatStick")
·Marlboro Green mint flavored HeatStick (formerly known as "Marlboro Smooth mint flavored HeatStick")
·Marlboro Blue mint flavored HeatStick (formerly known as "Marlboro Fresh mint flavored HeatStick")
Initial Modified Risk Tobacco Product Orders (MRGOs) issued in 2020 and 2022 are valid for a fixed period specified in the order. Philip Morris Product Company has submitted a renewal application for this MRTP in order for the FDA to determine if the product still meets the requirements of section 911(g)(2) of the Federal Food, Drug, and Cosmetic Act. The renewal application may reference other application documents, including the initial MRTP application submitted by the applicant, as well as post-market annual reports submitted in accordance with Premarket Tobacco Product Applications (PMTA) and MRTP application requirements. Annual reports for MRTP products must include cumulative results of post-market monitoring and studies conducted by the company as required by the Modified Risk Tobacco Product Orders.
On October 7, 2025, the Tobacco Products Scientific Advisory Committee (TPSAC) will convene a meeting to discuss the above MRTP renewal application. This meeting will be open to the public. For more information (including specific ways to submit written or oral comments), visit the "TPSAC Meeting Events Page".
After all the materials for the MRTP renewal application are released, the FDA will announce the deadline for the comment period. This deadline must meet two conditions: it must be no earlier than 180 days from the date of publication in the Federal Register, and no earlier than 30 days from the date of the FDA's final batch of application materials being released.
The latest batch of application materials from Philip Morris Product Company has been uploaded on September 25, 2025.
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