Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications
To Comment on the IQOS 3 MRTP Application
Submit comments including data, research, and other related information to docket FDA- 2021-N-0408 through December 10, 2021.
There may be conflicting deadlines posted on regulations.gov and federalregister.gov. While we cannot control how information is displayed on those websites, the docket will remain open through December 10, 2021.
FDA notified Philip Morris Products S.A. (PMPSA) that the applicant’s modified risk tobacco product (MRTP) application for the IQOS 3 System Holder and Charger is sufficiently complete to permit a substantive review.
Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted or check this webpage regularly. The latest set of application materials from Philip Morris Products S.A. were added on November 10, 2021.
The following application materials have been redacted in accordance with applicable laws:
Originally Submitted Applications:
- IQOS 3 System Holder and Charger Supplemental MRTP Application
- Cover Letter (PDF – 465 KB) – posted May 13, 2021
- Module 1: General Information
- 1.2 General Information (PDF – 1.4 MB) – posted May 13, 2021
- 1.3 Letters of Authorization (PDF – 58 KB) – posted May 13, 2021
- Module 2: Table of Contents, Glossary, Summary
- 2.2 Index of Files (PDF – 76 KB) – posted May 13, 2021
- 2.4 Executive Summary (PDF – 4 MB) – posted May 13, 2021
- Module 3: Product Description
- 3.1 Summary of the Product Formulation (PDF – 52 KB) – posted May 13, 2021
- 3.2 Summary of Manufacturing (PDF – 50 KB) – posted May 13, 2021
- Module 4: Labeling, Advertising
- 4.1 Labeling (PDF – 152 KB) – posted July 1, 2021
- 4.2 Marketing Plans (PDF – 1 MB) – posted July 1, 2021
- Module 5: Environmental Impact Assessment (PDF – 50 KB) – posted May 13, 2021
- Module 6: Research
- 6.1 Summary of Health Risk Investigations (PDF – 53 KB) – posted May 13, 2021
- 6.2 Conclusions (PDF – 50 KB) – posted May 13, 2021
- Module 7: Scientific Studies and Analyses (PDF – 48 KB) – posted May 13, 2021
- Module 8: Postmarket Information
- 8.1 Postmarket Surveillance and Studies Plan (PDF – 380 KB) – posted July 1, 2021
- Module 9: References (PDF – 48 KB) – posted May 13, 2021
- Appendices (ZIP – 17 MB) – posted July 1, 2021
Cross-referenced Submissions
- IQOS 3 System Holder and Charger Supplemental Premarket Tobacco Product Application (PMTA) (ZIP – 198 MB) – posted July 1, 2021, updated July 20, 2021
- Module 7, Section 7.1: Aerosol Characterization (ZIP – 70 MB) – posted July 20, 2021
- Module 7, Section 7.3: Human Studies (ZIP – 22 GB) – posted July 20, 2021
Amendments
- August 27, 2020 Amendment: Response to August 13, 2020, FDA Deficiency Letter – part 1 of 2 (ZIP – 2.5 MB) – posted November 10, 2021
- August 27, 2020 Amendment: Response to August 13, 2020, FDA Deficiency Letter – part 2 of 2 (ZIP – 2.4 MB) – posted November 10, 2021
Previously Reviewed Application(s)
- Executive Summary
- Module 1: Cover Letters
- Module 2: Table of Contents
- Module 3: Product Description and Formulation
- Module 4: Labels, Labeling, and Advertising
- Module 5: Environmental Impact
- Module 6: Summaries of All Research Findings
- Module 7: Scientific Studies and Analyses
- Module 8: Postmarket Surveillance and Studies
Amendments:
- December 20, 2019 Amendment: Response to November 20, 2019 FDA Information Request (.zip – 54 MB) (added January 24, 2020)
- January 25, 2017 Amendment: Confirmation on Applicant’s Name, List of Product Configurations, and Clarification of Modified Risk Claims (.zip – 260 KB) (added January 12, 2018)
- February 8, 2017 Amendment: Clarification on the Products Submitted for MRTP Review (.zip – 153 KB) (added January 12, 2018)
- March 16, 2017 Amendment: Response to March 2, 2017, FDA Advice and Information Request Letter (.zip – 56 MB) (originally added January 12, 2018)
FDA has also posted this amendment in 10 separate parts below.
- Part 1 of 10 (.zip - 233 MB) (posted December 17, 2018)
- Part 2 of 10 (.zip - 233 MB) (posted December 17, 2018)
- Part 3 of 10 (.zip - 937 MB) (posted December 17, 2018)
- Part 4 of 10 (.zip - 582 MB) (posted December 17, 2018)
- Part 5 of 10 (.zip – 1.0 GB) (posted December 17, 2018)
- Part 6 of 10 (.zip - 1.9 GB) (posted December 17, 2018)
- Part 7 of 10 (.zip - 3.2 GB) (posted December 17, 2018)
- Part 8 of 10 (.zip - 5.1 GB) (posted December 17, 2018)
- Part 9 of 10 (.zip - 3.4 GB) (posted December 17, 2018)
- Part 10 of 10 (.zip - 4.7 MB) (posted December 17, 2018)
May 15, 2017 Amendment: Re-submission of Data Previously Provided in the March 16, 2017, Amendment with Additional Study Reports and Data (.zip – 32 GB) (added February 23, 2018)
*This ZIP file includes several individual files. Depending on your internet connection speed and other factors, it may take a few minutes or up to several hours to download the ZIP file completely. FDA has also posted this amendment in 20 separate parts below:
- Part 1 of 20 (.zip - 7.1 MB) (posted December 17, 2018)
- Part 2 of 20 (.zip - 76.7 MB) (posted December 17, 2018)
- Part 3 of 20 (.zip - 36.1 MB) (posted December 17, 2018)
- Part 4 of 20 (.zip - 1.5 GB) (posted December 17, 2018)
- Part 5 of 20 (.zip - 5.1 GB) (posted December 17, 2018)
- Part 6 of 20 (.zip - 2.3 GB) (posted December 17, 2018)
- Part 7 of 20 (.zip - 4.2 GB) (posted December 17, 2018)
- Part 8 of 20 (.zip - 3.3 GB) (posted December 17, 2018)
- Part 9 of 20 (.zip - 555.2 MB) (posted December 17, 2018)
- Part 10 of 20 (.zip - 628.2 MB) (posted December 17, 2018)
- Part 11 of 20 (.zip - 4.1 GB) (posted December 17, 2018)
- Part 12 of 20 (.zip - 2.9 GB) (posted December 17, 2018)
- Part 13 of 20 (.zip - 1.5 GB) (posted December 17, 2018)
- Part 14 of 20 (.zip - 8.2 MB) (posted December 17, 2018)
- Part 15 of 20 (.zip - 4.2 GB) (posted December 17, 2018)
- Part 16 of 20 (.zip - 674.2 MB) (posted December 17, 2018)
- Part 17 of 20 (.zip - 30.3 MB) (posted December 17, 2018)
- Part 18 of 20 (.zip - 1.1 GB) (posted December 17, 2018)
- Part 19 of 20 (.zip - 23 MB) (posted December 17, 2018)
- Part 20 of 20 (.zip - 224.5 MB) (posted December 17, 2018)
- June 8, 2017 Amendment: Manufacturing Site Details for Inspection with Contacts (.zip – 2 MB) (added January 12, 2018)
- June 21, 2017 Amendment: Device Packaging and Tobacco Product Master File Letter of Authorization (added July 14, 2017)
- June 30, 2017 Amendment: Revised Manufacturing Schedule for Inspections (.zip – 1 MB) (added January 12, 2018)
- August 10, 2017 Amendment: Confirmation of Manufacturing Facility Inspection Dates (.zip – 900 KB) (added January 12, 2018)
- August 31, 2017 Amendment: Request for Extension on Response to August 4, 2017, FDA Advice and Information Request Letter (.zip – 110 KB) (added January 12, 2018)
- August 31, 2017 Amendment: Update on Activities of a Supplier (.zip – 500 KB) (added January 12, 2018)
- September 6, 2017 Amendment: Response to August 4, 2017, FDA Advice and Information Request Letter (.zip – 201 MB) (added February 23, 2018)
- September 8, 2017 Amendment: Response to August 4, 2017, FDA Advice and Information Request Letter (.zip – 67 MB) (added February 23, 2018)
- November 16, 2017 Amendment: Response to August 4, 2017, FDA Advice and Information Request Letter (.zip – 8 MB) (added February 23, 2018)
- December 8, 2017 Amendment: Response to August 4, 2017, FDA Advice and Information Request Letter including Non-targeted Differential Screening, Toxicological Assessment, and Peer Review Reports (.zip – 20 MB) (added January 12, 2018)
- December 22, 2017 Amendment: Response to November 22, 2017, FDA Advice and Information Request Letter (.zip – 36 MB) (added October 1, 2018)
- January 24, 2018 Amendment: Re-submission of Appendix provided on September 8, 2017 in response to August 4, 2017, FDA Advice and Information Request Letter to clarify figures (.zip – 646 KB) (added February 23, 2018)
- February 2, 2018 Amendment: Clarification of Ongoing “P1 Characterization” Study (.zip – 598 KB) (added October 1, 2018)
- February 26, 2018
- Amendment: Additional Information and Data from Six Recently Completed System Toxicology Studies and an Updated Clinical Study (.zip – 111 MB) (added October 18, 2018)
- Amendment: Submission of Updated Clinical Study (.zip – 2 GB) (added November 5, 2018)
- March 29, 2018 Amendment: Response to March 2, 2018, FDA Information Request Letter (.zip – 164 MB) (added August 17, 2018)
- April 26, 2018 Amendment: Submission of “P1 Characterization” Study (.zip – 25 MB) (added October 1, 2018)
- May 16, 2018 Amendment: Submission of Finalized Safety Update Report (SUR) (.zip – 4 MB) (added October 1, 2018)
- May 23, 2018 Amendment: Modification of Response to Question 1 Provided in April 23, 2018, to FDA Advice and Information Request Letter Based on Clarification by FDA (.zip – 80 MB) (added November 1, 2018)
- June 8, 2018 Amendment: Additional Information and Data from a Recently Completed Clinical Study (.zip – 1.3 GB) (added November 29, 2018)
- June 13, 2018 Amendment: Response to June 6, 2018, FDA Information Request (.zip – 3 MB) (added October 18, 2018) August 3, 2018 Amendment: Response to July 18, 2018, FDA Information Request (.zip – 57 MB) (added October 18, 2018)
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.
- Part 1 of 7 (.zip - 491.5 MB) (posted December 17, 2018)
- Part 2 of 7 (.zip - 794.6 MB) (posted December 17, 2018)
- Part 3 of 7 (.zip - 28.7 MB) (posted December 17, 2018)
- Part 4 of 7 (.zip - 16.8 MB) (posted December 17, 2018)
- Part 5 of 7 (.zip - 25.6 MB) (posted December 17, 2018)
- Part 6 of 7 (.zip - 8.4 MB) (posted December 17, 2018)
- Part 7 of 7 (.zip - 3.7 MB) (posted December 17, 2018)
- August 31, 2018 Amendment: Submission of FDA Requested Tabulated Index of Scientific References (.zip – 1.8 MB) (added October 1, 2018)
- September 21, 2018 Amendment: Submission of an Amended Study Report as part of “P1 Characterization” and an Updated Clinical Study (.zip – 376 MB) (added November 29, 2018)
- October 23, 2018 Amendment: Submission of Two Amended Preclinical Studies (.zip – 52 MB) (added November 9, 2018)
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, 2018))
- 7.1 Product Analyses (.zip – 13 MB)
- 7.2 Preclinical Studies (.zip – 86 MB)
- Additional Preclinical files (472 MB) (added December 17, 2018)
- 7.3 Studies in Adult Human Subjects
- 7.3.1 Clinical Studies – (added November 28, 2017; updated January 24, 2018)
- Additional Clinical files (953 MB) (added December 17, 2018)
- 7.3.2 Perception and Behavior Assessment Studies – (added November 28, 2017; updated January 24, 2018)
- Additional Perception and Behavior Assessment files (337 MB) (added December 17, 2018)
- 7.3.3. Whole Offer Tests (.zip – 3 MB)
- 7.3.1 Clinical Studies – (added November 28, 2017; updated January 24, 2018)
- 7.4 Population Health Impact Model (.zip – 145 MB)
- 7.5 Mechanistic and Systems Toxicology (Systox) Studies (.zip – 207 MB)
- PMP S.A. Product Description, Formulation, Labeling, and Advertising for IQOS & HeatStick Products (.zip - 159 MB), including: (added July 14, 2017)
- Module 3: Product Description and Formulation
- Module 4: Labels, Labeling, and Advertising
- Amendment: Device Packaging and Tobacco Product Master File Letter of Authorization
- PMP S.A. Executive Summary (PDF - 5.74 MB) (added May 24, 2017)
- PMP S.A. Summaries of Research Findings on IQOS & HeatStick Products (.zip - 75.4 MB), including: (added May 24, 2017)
- Module 1: Cover Letters
- Module 2: Table of Contents (includes executive summary)
- Module 5: Environmental Impact
- Module 6: Summaries of All Research Findings
- Module 8: Postmarket Surveillance and Studies
Temporary Compliance Waiver Notice
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 [email protected] or call 1-877-287-1373.
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
- FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information
- Public Docket for IQOS System Modified Risk Tobacco Product Applications
- FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway
- Tobacco Products Scientific Advisory Committee: January 2018 Meeting Materials
- Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications
- TPSAC Meetings on MRTP Applications
- MRTP Overview