Scientist Mikael Franzon talks about reduced-risk product research.

Want to learn more about the science behind heat-not-burn technology?

Heat-Not-Burn Reduced Risk
Since 1965, smoking rates have decreased by more than half, but 42 million Americans still smoke.
Nicotine and Harm Reduction
How safe is nicotine use? What are the health risks associated with nicotine?
Reduced Risk Potential
Products With Reduced-Risk Potential: An innovative way to address the harm caused by smoking?
Heat-Not-Burn Clinical Assessment
Clinical assessment is the cornerstone of Philip Morris International’s scientific program.

Scientist Mikael Franzon talks about reduced-risk product research.

Want to learn more about the science behind heat-not-burn technology?

Since 1965, smoking rates have decreased by more than half, but 42 million Americans still smoke.
How safe is nicotine use? What are the health risks associated with nicotine?
Products With Reduced-Risk Potential: An innovative way to address the harm caused by smoking?
Clinical assessment is the cornerstone of Philip Morris International’s scientific program.
Scientific Review

FDA’s review of Philip Morris International’s Modified Risk Tobacco Product Application

On May 24, 2017, FDA initiated substantive scientific review of PMI’s application.

Heat-Not-Burn

The Heat-Not-Burn Concept

The lit end of a cigarette can reach temperatures in excess of 1600 °F. PMI’s product development is based on technologies, which produce a nicotine-containing aerosol without combustion.

Science Behind Heat-Not-Burn

The Science Behind Heat-Not-Burn

Philip Morris International has completed a broad range of laboratory and clinical studies on Tobacco Heating System, a candidate heat-not-burn modified risk tobacco product.

PMI Science

Get the latest from PMI Science.

January 2018

PMI presents heat-not-burn technology to TPSAC

1/24/2018

Philip Morris International (PMI) presented to the Tobacco Products Scientific Advisory Committee (TPSAC) on January 24, 2017 as part of the review of PMI’s Modified Risk Tobacco Product Application (MRTPA), which is pending before the FDA. This presentation provides a thorough overview of the THS system and heat-not-burn technology, scientific assessment results, behavior data, plans for the introduction of THS to the United States, and population health impact modeling.

Review the full presentation here.

Review of Biomarkers to Assess the Effects of Switching From Cigarettes to Modified Risk Tobacco Products

1/09/2018

In this publication, the authors review the pros and cons for using several biomarkers as indicators of effects of changing from conventional cigarettes to modified risk products. The literature indicates that not all assessed biomarkers return to baseline levels following smoking cessation during the study periods, but nine had potential for use in medium- to long-term studies.

December 2017

Effects of Cigarette Smoking on Color Stability of Dental Resin Composites

12/30/2017

This peer-reviewed publication describes the results of a study on the effects of cigarette smoke on the discoloration of dental resin composite compared to the aerosol from a heat-not-burn tobacco product, the Tobacco Heating System 2.2. While cigarette smoke caused significant discoloration of dental composite resins, reducing or eliminating the deposits derived from the combustion of tobacco showed the potential to minimize the impact of smoking on the color of composite resin restorations.

Quantifying Risk-Reduction Potential of New Modified Risk Tobacco Products

12/16/2017

This peer-reviewed publication describes a methodology that allows for translating biomarker measurements into excess risks by estimating a product-specific risk-modulating effective dose. The methodology bridges the gap between the need for quantitative disease- and product-specific health impact assessment on one hand, and the lack of epidemiological data on the other, for novel tobacco products.

Read Interview with PMI Director of Medical Affairs, Dr. Patrick Picavet

12/11/2017

Dr. Patrick Picavet, a physician by training, joined PMI over seven years ago after working in the University Hospital in Mannheim and afterwards in the pharmaceutical industry. Since then, Patrick has held several roles in PMI, including Director, Clinical Assessment, in which he was responsible for the planning and execution of clinical studies on our smoke-free products. Since early 2017, as Director, Medical Affairs, Patrick is helping establish the next steps in the strategy for PMI’s assessment program and supports PMI’s efforts to inform the scientific and medical communities about PMI science. Read more

Scientific Update for Smoke-Free Products Looks at Best Research Practices

12/2017

This scientific update provides a closer look at some of the principles and practices on which PMI’s scientific assessment program is built, including examples from PMI’s clinical program that highlight the company’s commitment to the use of best practices, transparent research, and the well-being of clinical trial participants.

November 2017

FDA Posts New Materials on PMI’s MRTPA

11/28/2017

On November 28, FDA posted data from clinical studies, consumer perception studies, and behavioral assessments from modified risk tobacco product (MRTP) applications submitted by Philip Morris International for its IQOS tobacco heating system. The originally submitted applications (redacted in accordance with applicable laws) are now publicly available. FDA anticipates to make amendments received thus far publicly available over the next several months, and amendments received in the future will be made publicly available as they are redacted. To review the application, click here.

FDA Announces Extension for Public Comment

11/22/2017

On November 22, the Food and Drug Administration (FDA) announced an extension of the public comment period on modified risk tobacco product applications (MRTPAs) submitted by Philip Morris International (PMI) for its IQOS tobacco heating system. Once all documents from the MRTPAs, including amendments, are posted, FDA intends to issue a notice in the Federal Register announcing when the comment period will close, which will be no earlier than 30 days from the date the last batch of application documents is posted.

More Data from PMI MRTP Applications Now Available Online

11/9/2017

On November 9, FDA posted some study reports and datasets from modified risk tobacco product (MRTP) applications submitted by PMI. These materials add to the information previously made public after FDA filed the applications for substantive scientific review on May 24. FDA plans to post the remaining documents of the originally submitted applications by November 24, 2017. Amendments received thus far and any received in the future will be posted at a later date. As stated in previous guidance, FDA will extend the comment period to allow for 30 days or more of public comment from the date the last amendment is posted.

FDA Announces Public Advisory Committee Meeting of the TPSAC

11/9/2017

On November 9, FDA published a Federal Register notice announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) scheduled for January 24-25, 2018, at the FDA White Oak campus. The committee will discuss scientific issues related to the modified risk tobacco product (MRTP) applications submitted by PMI, which are currently under scientific review by FDA.

PMI Presents at ISPOR 20th Annual European Congress

11/8/2017

On November 8, PMI presented at the International Society for Pharmacogenomics and Outcomes Research (ISPOR) 20th Annual European Congress. ISPOR is the leading global scientific and educational organization for health economics and outcomes research (HEOR). ISPOR’s mission is to promote HEOR excellence to improve decision making for health globally.

PMI presented two posters:

Measuring Changes in Patterns of Tobacco Product Use Over Time: Transition Probability Approaches

Using Rasch Measurement to Quantify the Perceived Risks Associated with the Use of Tobacco and Nicotine-Containing Products

PMI Initiates a Clinical Trial Investigating the Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome

11/7/2017

The purpose of this study is to demonstrate in patients with generalized chronic periodontitis that switching from cigarettes to IQOS improves the response to periodontal therapy and the overall oral health status compared to continued cigarette smoking.

Smoke versus non-smoke aerosols

11/2017

PMI published a brief paper explaining the difference between smoke and non-smoke aerosols. Tobacco Heating System (THS) is one of the innovative non-combustible products that heat tobacco to generate an aerosol that is not smoke, and that is fundamentally different in origin, chemical and physical composition to cigarette smoke.


October 2017

PMI Presents at CORESTA Smoke Science and Product Technology Joint study Groups Meeting

10/2017

PMI presented six posters on candidate modified risk tobacco products at the CORESTA Smoke Science and Product Technology Joint Study Groups Meeting held in Kitzbühel, Austria, on 8-12 October 2017.

Comparative Effects Of A Candidate Modified-Risk Tobacco Product Aerosol & Cigarette Smoke On Human Organotypic Small Airway Cultures

10/2017

The study assessed the biological impact of an aerosol from a candidate modified-risk tobacco product, Tobacco Heating System (THS) 2.2, to investigate the potential reduced risk of THS2.2 aerosol exposure compared with cigarette smoke. The effects of the THS2.2 aerosol exposure on the small airway cultures were compared with those of 3R4F cigarette smoke using a systems toxicology approach whereby elucidation of toxic effects is derived not only from functional assay readouts but also from omics technologies. The study demonstrated that the systems toxicology approach can reveal changes at the cellular level that would be otherwise not detected from functional assays, thus increasing the sensitivity to detect potential toxicity of a treatment/exposure.


September 2017

August 2017

Comparative assessment of HPHC yields in Tobacco Heating System (THS 2.2) and commercial cigarettes

8/16/2017

In this peer-reviewed publicationthe authors compare the levels of harmful and potentially harmful constituents (HPHC) measured in the aerosol of THS, a heat-not-burn candidate modified risk tobacco product, with the levels of HPHCs of cigarettes representative of selected countries. The study shows that the levels of HPHCs delivered are reduced by about 90% on average compared to commercially available cigarettes.


PMI Science THS Executive Summary

8/16/2017

This document summarizes the results of PMI’s scientific assessment program for Tobacco Heating System (THS 2.2), a heat-not-burn candidate modified risk tobacco product. The document also includes an up-to-date listing of relevant peer-reviewed publications.


July 2017

Nicotine pharmacokinetic profiles of Tobacco Heating System (THS 2.2), cigarettes and nicotine gum in Japanese smokers

7/31/2017

In this peer-reviewed publicationthe authors present the results of two open-label randomized cross-over studies in Japanese smokers investigating the single-use nicotine pharmacokinetic profile of the Tobacco Heating System (THS 2.2), cigarettes (CC) and nicotine replacement therapy (gum). The THS nicotine pharmacokinetic profile was close to CC, with similar levels of urge-to-smoke. This suggests that THS can satisfy smokers and be a viable alternative to cigarettes for adult smokers who want to continue using tobacco.


Solid particle investigation in the mainstream of 3R4F reference combustible cigarettes, and the Tobacco Heating System THS2.2

7/27/2017

This poster presents the result of an investigation to evaluate whether combustion-related particles were released in the mainstream aerosol from Tobacco Heating System (THS 2.2), a heat-not-burn candidate modified risk tobacco product. The poster was presented at the 21st ETH-Conference on Combustion Generated Nanoparticles.


June 2017

Introducing a Reduced Risk Tobacco Product in the USA: Estimating the impact of differing assumptions on the population health

6/2017

In this peer-reviewed publication, the authors assess the effects on U.S. tobacco prevalence and the mortality of introducing a Reduced Risk Tobacco Product (RRP) using Population Health Impact Modelling. The authors also study extreme situations (e.g. everyone using RRP), and investigate assumptions, which might eliminate the RRP-related mortality reduction.

FDA announces MRTPA is open for public comment

6/2017

FDA is announcing the availability for public comment of Modified Risk Tobacco Product Applications (MRTPAs) for PMI’s heat-not-burn tobacco product on June 15, 2017. The comment period will close on December 12, 2017. Comments can be submitted here.

Review PMI’s peer-reviewed publications for THS 2.2, a candidate modified risk tobacco product

6/2017

A complete list of references and abstracts for articles describing PMI’s studies conducted with Tobacco Heating System (THS 2.2), a heat-not-burn candidate Modified Risk Tobacco Product (MRTP), can be found here.

May 2017

PMI responds to study by Auer et al. examining constituents in Tobacco Heating System

5/30/2017

Please click here to read PMI’s review of the research letter published Auer et al. in JAMA Intern Med. on May 22, 2017. Auer et al. compared the levels of selected harmful and potentially harmful constituents (HPHCs) in the aerosol of Tobacco Heating System (THS) with the levels in smoke from conventional cigarette. The levels of some HPHCs in cigarette smoke reported by Auer et al. differ dramatically from the values reported in peer-reviewed studies and as a result the authors concluded that the levels of some HPHCs in the aerosol of THS were not significantly reduced, or were as high as or higher than in cigarette smoke.

FDA accepts for substantive scientific review three modified risk tobacco product (MRTP) applications submitted by Philip Morris International.

5/25/2017

FDA is making these redacted applications, including PMI’s 208-page executive summary publicly available on this link. An abbreviated summary is available here. A Federal Register notice establishing a formal docket for public comments on Regulations.gov will be published in the coming weeks. Due to the large size of PMI’s applications, FDA will post additional documents related to the application on a rolling basis.

PMI to present at Global Forum on Nicotine in June

5/4/2017

PMI will present at the upcoming Global Forum on Nicotine in Warsaw from June 15, 2017 to June 17, 2017. For a full list of PMI’s presentations and posters, please click here.

March 2017

Philip Morris International (PMI) Files Premarket Tobacco Product Application for its Electronically Heated Tobacco Product (EHTP) with the US Food and Drug Administration (FDA)

3/31/2017

Philip Morris International Inc. (“PMI”) (NYSE / Euronext Paris: PM) submitted a Premarket Tobacco Product Application (PMTA) for its Electronically Heated Tobacco Product (EHTP) to the US Food and Drug Administration’s (FDA) Center for Tobacco Products. This is consistent with the Company’s stated goal of submitting its PMTA in the first Quarter of 2017.

Press Release

Actual Use of the Candidate Modified Risk Tobacco Product (MRTP): Tobacco Heating System (THS)

3/2017
S Roulet, P Magnani, G Kallischnigg, A Dugan, C Gage, C Kanitscheider, M Apecechea, A Ramazotti

Poster

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Modeling the Impact of Changes in Tobacco Use on Individual Disease Risks

3/2017
G Baker, Z Sponsiello Wang, S Djurdjevic, PN Lee, J Fry, F Lüdicke, R Weitkunat

Poster

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Intention to Use the Tobacco Heating System, Associated with Variants of a Potential Product Brochure

3/2017
F Beacher, P Magnani, A Ramazotti, R Weitkunat, G Kallischnigg, S Colman, T Alfieri

Poster

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Perceived Health Risk of the Tobacco Heating System and Comparators, Associated with Variants of a Potential Product Brochure

3/2017
F Beacher, P Magnani, A Ramazotti, R Weitkunat, G Kallischnigg, S Colman, T Alfieri

Poster

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Nicotine Population Pharmacokinetics in Healthy Adult Smokers

3/2017
P Brossard, M Marchand, N Lama, R Weitkunat, H Merdjan, F Lüdicke

Peer Review Publication

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February 2017

PMI’s Investigator Initiated Studies (IIS) Program to support new clinical trial

2/14/2017

PMI plans to support a new clinical trial under the Investigator Initiated Studies (IIS) Program. The study, registered on Australian New Zealand Clinical Trials Registryaims to compare exposure to selected harmful and potentially harmful constituents of those switching to the THS device compared to continued conventional cigarette smoking and smoking abstinence. The study will be conducted in Maori / Pacific Islander population in New Zealand. A full list of studies supported under this pilot program is available here.

Development of Models for the Estimation of Mouth Level Exposure to Aerosol Constituents from a Heat-Not-Burn Tobacco Product Using Mouthpiece Analysis

2/2017
L Poget, P Campelos, C Jeannet, S Maeder

Peer Review Publication

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Effects of Switching to Menthol THS2.2, Smoking Abstinence, or Continued Cigarette Smoking on Clinically Relevant Risk Markers: A Randomized, Controlled, Open-Label, Multicenter Study in Sequential Confinement and Ambulatory Settings (Part 2)

2/2017
F Lüdicke, P Picavet, G Baker, C Haziza, V Poux, N Lama, R Weitkunat

Peer Review Publication

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Effects of Switching to Tobacco Heating System 2.2 Menthol, Smoking Abstinence, or Continued Cigarette Smoking on Biomarkers of Exposure: A Randomized, Controlled, Open-Label, Multicenter Study in Sequential Confinement and Ambulatory Settings (Part 1)

2/2017
F Lüdicke, P Picavet, G Baker, C Haziza, V Poux, N Lama, R Weitkunat

Peer Review Publication

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January 2017

Aerosol from Tobacco Heating System 2.2 has reduced impact on mouse heart gene expression compared with cigarette smoke

1/17
J Szostak, S Boue, M Talikka, E Guedj, F Martin, B Phillips, N Ivanov, MC Peitsch, J Hoeng

Peer Review Publication

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December 2016

Philip Morris International (PMI) Announces Filing of Application for Its Electronically Heated Tobacco Product with the US Food and Drug Administration (FDA)

12/16/2016

Philip Morris International Inc. (“PMI”) (NYSE / Euronext Paris: PM) on Dec. 5 submitted a Modified Risk Tobacco Product (MRTP) application for its electronically heated tobacco product with the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products. This is consistent with the company’s stated goal of submitting its MRTP application in 2016. PMI anticipates the FDA taking a minimum of 60 days to complete an administrative review to determine whether to accept the application for substantive review.

Press Release

November 2016

Biomarker of exposure level data set in smokers switching from conventional cigarettes to Tobacco Heating System 2.2, continuing smoking or abstaining from smoking for 5 days

11/18/2016
C Haziza et al.

Peer Review Publication

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Evaluation of the Tobacco Heating System 2.2 (THS2.2). Part 5: microRNA expression from a 90-day rat inhalation study indicates that exposure to THS 2.2 aerosol causes reduced effects on lung tissue compared with cigarette smoke

11/17/2016
A Sewer et al.

Peer Review Publication

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A systems toxicology approach for comparative assessment: Biological impact of an aerosol from a candidate modified-risk tobacco product and cigarette smoke on human organotypic bronchial epithelial cultures

11/16/2016
A Iskandar et al.

Peer Review Publication

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Evaluation of the Tobacco Heating System 2.2. Part 9: Application of systems pharmacology to identify exposure response markers in peripheral blood of smokers switching to THS2.2

11/11/2016
F Martin et al.

Peer Review Publication

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Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland

11/4/2016
C Haziza et al.

Peer Review Publication

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Evaluation of the Tobacco Heating System 2.2. Part 6: 90-day OECD 413 rat inhalation study with systems toxicology endpoints demonstrates reduced exposure effects of a mentholated version compared with mentholated and non-mentholated cigarette smoke

11/4/2016
A Oviedo et al.

Peer Review Publication

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