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          Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) ApplicationsAdvertising and Promotion Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications
  
  	
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    PrintOn March 11, 2022, FDA issued a modified risk granted order authorizing Philip Morris Product S.A. to market the IQOS 3 System Holder and Charger 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.”As of November 2021, IQOS and Heatsticks are currently subject to a limited exclusion order and cease-and-desist order issued by the U.S. International Trade Commission which restricts the sales, distribution and marketing of the products in the United States.

See the Modified Risk Granted Orders webpage for the order letter and decision summary relevant to this MRTP application.

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 **November 10, 2021**.

Previously Reviewed Application(s)

***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.*

IQOS 3 System Holder and Charger
	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**

3/11/2022 – Received Modified Risk Granted Order
	FDA Authorizes Reduced Exposure Claim for IQOS 3 System Holder and Charger
	12/7/2020 – Received Marketing Granted OrderIQOS Tobacco Heating System
	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 to Part 10 (posted December 17, 2018)

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 to Part 20 (posted December 17, 2018)

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 to Part 7 (posted December 17, 2018)

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)
		7.4 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 AuthorizationPMP 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

IQOS 2.4 Tobacco Heating System

7/7/2020 – Received Modified Risk Granted Order
	FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information
	4/30/2019 – Received Marketing Granted Order
	FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway***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

Public Docket for IQOS System Modified Risk Tobacco Product Applications
	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

                                                                                  Content current as of:
      03/11/2022
              
              
Regulated Product(s)
		 TobaccoAdvertising and Promotion

          
                        Modified Risk Tobacco Products
 
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