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Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications
FDA previously issued modified risk granted orders (MRGOs) authorizing Philip Morris Products S.A. to market the following products:
IQOS 2.4 System Holder and Charger and HeatSticks (Authorized July 7, 2020)
IQOS 3.0 System Holder and Charger (Authorized March 11, 2022)
These products were authorized 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.”
See the Modified Risk Granted Orders webpage for the order letter and decision summary relevant to these MRTP applications.
Marlboro Amber HeatSticks (formerly named Marlboro HeatSticks)
Marlboro Green Menthol HeatSticks (formerly named Marlboro Smooth Menthol HeatSticks)
Marlboro Blue Menthol HeatSticks (formerly named Marlboro Fresh Menthol HeatSticks)
The original 2020 MRTP orders and 2022 MRTP orders are valid for the fixed time period specified in the order. To continue marketing an MRTP after the term of an order, the company may submit an MRTP renewal application for FDA to determine that the product still satisfies the requirements in section 911(g)(2) of the Federal Food, Drug, and Cosmetic Act. Renewal applications may cross-reference an applicant’s original MRTP as well as postmarket annual reports submitted in accordance with marketing order requirements for both the premarket tobacco application (PMTA) and MRTP. Annual reports for MRTPs contain the cumulative results from the postmarket surveillance and studies that all companies are required to conduct as part of a modified risk granted order.
Once all materials from these MRTP renewal applications are posted, FDA will announce the closing date for the comment period, which will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials.
Please sign up to receive email alertsExternal Link Disclaimer when any MRTP application materials have been posted or check this webpage regularly. The latest set of application materials from Philip Morris Products S.A. were added on May 9, 2024.
Materials and Related Documents
Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.
Materials related to actions include:
IQOS Devices and HeatSticks – MRTP Renewal Applications — Posted May 9, 2024
August 30, 2018 Amendment: Submission of Finalized In Vivo Study (.zip – 900 KB) (originally added November 26, 2018). FDA has also posted this amendment in seven separate parts below.
History of original application documents posted (most recent at the top):
PMP S.A. Module 7: Scientific Studies and Analyses: (added November 9, 2017; updated November 28, 2017 and January 24, 2018, and December 17, 2018External Link Disclaimer))
Note: FDA is required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make MRTP applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications.
