1. Home
  2. Tobacco Products
  3. Products, Guidance & Regulations
  4. Advertising and Promotion
  5. Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications
  1. Advertising and Promotion

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 with specific reduced exposure claims:

  • 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 to be marketed 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.

On May 9, 2024, FDA filed for scientific review modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for the following products: 

  • IQOS 2.4 System Holder and Charger
  • IQOS 3.0 System Holder and Charger
  • 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 and 2022 MRGOs are valid for the fixed time period specified in the order. Philip Morris Products S.A  submitted an MRTP renewal application for FDA to determine whether the product still satisfies the requirements in section 911(g)(2) of the Federal Food, Drug, and Cosmetic Act. Renewal applications may cross-reference other applications, including an applicant’s original MRTP application as well as postmarket annual reports submitted in accordance with order requirements for both the premarket tobacco application (PMTA) and MRTP application. 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. 

On October 7, 2025, the Center for Tobacco Products (CTP) held a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting to discuss the MRTP renewal applications. The meeting was open to the public via live webcast. Visit the TPSAC meeting event page to learn more.  

All the materials from these MRTP renewal applications have been posted. On November 6, 2025, FDA established a deadline for public comments. Public comments must be submitted to the appropriate docket by 11:59 p.m. ET on December 8, 2025, to ensure they are considered by FDA:

Please sign up to receive email alerts 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 September 25, 2025.

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

Cross-Referenced Submissions 

Postmarket Submissions

Previously Reviewed Application(s)

Original PMTA and Amendment for IQOS 3.0 System Holder and Charger (Authorized December 7, 2020) — Posted May 9, 2024 (zip – 205MB)

IQOS 2.4 Tobacco Heating System 

Original PMTA and Amendments for IQOS 2.4 System Holder and Charger and HeatSticks (Authorized April 30, 2019) — Posted May 9, 2024 (zip – 966MB)

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.

Additional Resources

 

Back to Top