scholarly journals IQOS: examination of Philip Morris International’s claim of reduced exposure

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s30-s36 ◽  
Author(s):  
Gideon St.Helen ◽  
Peyton Jacob III ◽  
Natalie Nardone ◽  
Neal L Benowitz
Keyword(s):  
Cigarette Smoke ◽  
Systemic Exposure ◽  
Tobacco Product ◽  
Global Market ◽  
Mainstream Smoke ◽  
Aerosol Chemistry ◽  
Philip Morris ◽  
The Usa ◽  
Human Exposure Assessment ◽  
The Impact

BackgroundNew electronic heated tobacco products are being introduced in the global market and are gaining popularity. In 2016, Philip Morris International, Inc. (PMI) submitted a modified risk tobacco product (MRTP) application to the Food and Drug Administration (FDA) to market IQOS in the USA with claims of reduced exposure and reduced risk.MethodsWe examined PMI’s MRTP application, specifically sections on aerosol chemistry and human exposure assessment, to assess the validity of PMI’s claims of reduced exposure and risk.FindingsPMI reported levels for only 40 of 93 harmful and potentially harmful constituents (HPHCs) on FDA’s HPHC list in IQOS mainstream aerosol. All substances in PMI’s list of 58 constituents (PMI-58) were lower in IQOS emissions compared with mainstream smoke of 3R4F reference cigarettes. However, levels of 56 other constituents, which are not included in the PMI-58 list or FDA’s list of HPHCs, were higher in IQOS emissions; 22 were >200% higher and seven were >1000% higher than in 3R4F reference cigarette smoke. PMI’s studies also show significantly lower systemic exposure to some HPHCs from use of IQOS compared with smoking combustible cigarettes.ConclusionPMI’s data appear to support PMI’s claim that IQOS reduces exposure to HPHCs. However, PMI’s data also show significantly higher levels of several substances that are not recognised as HPHCs by the FDA in IQOS emissions compared with combustible cigarette smoke. The impact of these substances on the overall toxicity or harm of IQOS is not known.

FDA’s reduced exposure marketing order for IQOS: why it is not a reliable global model

2021 ◽  
pp. tobaccocontrol-2020-056316
Author(s):  
Lauren Kass Lempert ◽  
Stella Bialous ◽  
Stanton Glantz
Keyword(s):  
Public Relations ◽  
Tobacco Control ◽  
Scientific Evidence ◽  
Tobacco Product ◽  
Tobacco Products ◽  
Sales And Marketing ◽  
Philip Morris ◽  
The Us ◽  
The Usa ◽  
The Difference

The US Food and Drug Administration (FDA) issued orders in July 2020 authorising Philip Morris Products S.A. to market its heated tobacco product (HTP) IQOS inside the USA with claims that it reduces exposure to some dangerous substances. FDA’s ‘reduced-exposure’ orders explicitly prohibit the marketing of IQOS with claims that IQOS will reduce harm or the risk of tobacco-related diseases. Under US law, FDA’s IQOS orders are problematic because FDA disregarded valid scientific evidence that IQOS increases exposure to other dangerous toxins and that Philip Morris Products S.A. failed to demonstrate that consumers understand the difference between reduced-exposure and reduced-harm claims. Unfortunately, both ‘reduced-exposure’ and ‘reduced-harm’ are classified as ‘modified risk tobacco products’ under US law. Exploiting this confusion, Philip Morris International used the FDA decision as the basis for marketing and public relations campaigns outside the USA to press governments to reverse policies that ban or regulate the sales and marketing of HTPs, including IQOS. Parties to the WHO Framework Convention on Tobacco Control should reject tobacco companies’ unsubstantiated explicit or implied claims of reduced harm associated with HTPs and resist Philip Morris International’s and other companies’ calls to relax HTP regulations based on the FDA’s actions. Instead, parties should adopt policies aligned with the Framework Convention on Tobacco Control when dealing with HTPs and other novel tobacco products.

Robustness of HPHC Reduction in THS 2.2 Aerosol Relative to 3R4F Reference Cigarette Smoke under Extreme Climatic Conditions

2021 ◽  
Vol 30 (3) ◽  
pp. 109-126
Author(s):  
Laurent Poget ◽  
Catherine Goujon ◽  
Samuel Kleinhans ◽  
Serge Maeder ◽  
Jean-Pierre Schaller
Keyword(s):  
Cigarette Smoke ◽  
Heating System ◽  
Tobacco Product ◽  
Climatic Conditions ◽  
Mainstream Smoke ◽  
Humid Climate ◽  
Experimental Conditions ◽  
Puff Volume ◽  
Temperature And Humidity ◽  
Health Canada

Summary In order to assess robustness for the reduction of harmful and potentially harmful constituent (HPHC) levels generated by the Tobacco Heating System 2.2 (THS 2.2), a heated tobacco product, we compared the aerosol of this product with mainstream smoke from the 3R4F reference cigarette under different conditions of temperature and humidity. The desired climatic conditions were achieved by using an air-conditioning system coupled with the smoking-machine housing. Two extreme climatic conditions were selected, representing a “Hot and Dry” climate (30 °C and 35% relative humidity RH) and a “Hot and Very Humid” climate (30 °C and 75% RH). In addition, aerosol and smoke were generated using the standard conditions recognized for smoking-machine analyses of tobacco products (22 °C and 60% RH), which were close to the climatic conditions defined for “Subtropical and Mediterranean” environments (25 °C and 60% RH). The experimental conditions were chosen to simulate the use of THS 2.2 and cigarettes under extreme conditions of temperature and humidity. HeatSticks and cigarettes taken from freshly opened packs were subjected to short-term conditioning from two to a few more days under the same experimental conditions. We analyzed 54 HPHCs in THS 2.2 aerosol and 3R4F cigarette smoke, generated in accordance with the Health Canada Intense (HCI) standard, using modified temperature and humidity conditions for sample conditioning and machine-smoking experiments. We used a volume-adjusted approach for comparing HPHC reductions across the different climatic conditions investigated. Although a single puffing regimen was used, the total puff volume recorded for the 3R4F cigarette smoke varied due to the influence of temperature and humidity on combustion rate, which justified the use of a volume-adjusted approach. Volume-adjusted yields were derived from HPHC yields expressed in mass-per-tobacco stick normalized per total puff volume. The results indicated that, regardless of the considered climatic conditions, the HPHC levels investigated in THS 2.2 aerosol were reduced by at least 90%, on average, when compared with the concentrations in 3R4F cigarette mainstream smoke. This confirmed the robustness in performance for THS 2.2 to deliver reduced levels of HPHCs under the extreme climatic conditions investigated in this study. In order to further characterize the robustness of these reductions, the lowest reduction performance achieved for individual HPHCs across all climatic conditions was used to define the threshold for a robust reduction. The majority of the 54 HPHCs investigated in THS 2.2 aerosol showed more than 90% reduction. Calculations derived from nicotine-adjusted yields also confirmed robust reductions for all investigated HPHCs. The small differences in absolute reduction between the volume- and nicotine-adjusted approaches were predominantly attributed to a combination of the differences in both nominal nicotine deliveries and total puff volumes between THS 2.2 and 3R4F cigarettes; however, this did not influence the determination of robustness. Our findings confirm the value of this approach for assessing the robustness of a product’s performance under different climatic conditions.

scholarly journals Modelling the impact of a new tobacco product: review of Philip Morris International’s Population Health Impact Model as applied to the IQOS heated tobacco product

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s82-s86 ◽  
Author(s):  
Wendy B Max ◽  
Hai-Yen Sung ◽  
James Lightwood ◽  
Yingning Wang ◽  
Tingting Yao
Keyword(s):  
Population Health ◽  
New Product ◽  
Health Impact ◽  
Tobacco Product ◽  
Dynamic State ◽  
Model Parameters ◽  
Impact Model ◽  
Tobacco Products ◽  
Philip Morris ◽  
The Impact

ObjectivesWe review the Population Health Impact Model (PHIM) developed by Philip Morris International and used in its application to the US Food and Drug Administration (FDA) to market its heated tobacco product (HTP), IQOS, as a modified-risk tobacco product (MRTP). We assess the model against FDA guidelines for MRTP applications and consider more general criteria for evaluating reduced-risk tobacco products.MethodsIn assessing the PHIM against FDA guidelines, we consider two key components of the model: the assumptions implicit in the model (outcomes included, relative harm of the new product vs cigarettes, tobacco-related diseases considered, whether dual or polyuse of the new product is modelled, and what other tobacco products are included) and data used to estimate and validate model parameters (transition rates between non-smoking, cigarette-only smoking, dual use of cigarettes and MRTP, and MRTP-only use; and starting tobacco use prevalence).ResultsThe PHIM is a dynamic state transition model which models the impact of cigarette and MRTP use on mortality from four tobacco-attributable diseases. The PHIM excludes morbidity, underestimates mortality, excludes tobacco products other than cigarettes, does not include FDA-recommended impacts on non-users and underestimates the impact on other population groups.ConclusionThe PHIM underestimates the health impact of HTP products and cannot be used to justify an MRTP claim. An assessment of the impact of a potential MRTP on population health should include a comprehensive measure of health impacts, consideration of all groups impacted, and documented and justifiable assumptions regarding model parameters.

scholarly journals Heated tobacco products likely appeal to adolescents and young adults

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s41-s47 ◽  
Author(s):  
Karma McKelvey ◽  
Lucy Popova ◽  
Minji Kim ◽  
Benjamin W Chaffee ◽  
Maya Vijayaraghavan ◽  
...  
Keyword(s):  
Health Risks ◽  
Tobacco Industry ◽  
Tobacco Product ◽  
Adolescent And Young Adult ◽  
Tobacco Products ◽  
Design And Implementation ◽  
Philip Morris ◽  
The Us ◽  
The Usa ◽  
The 1960S

BackgroundBeginning in the 1960s in the USA and globally since 1998, tobacco companies have beenaggressively promoting heated tobacco products (HTP). In 2016, Philip Morris International (PMI) applied to the US Food and Drug Administration (FDA) seeking authorisation to market their IQOS HTP system and flavoured ‘HeatSticks’ in the USA as a modified-risk tobacco product (MRTP).MethodsWe systematically evaluated the publicly available data PMI submitted to FDA in its MRTP application to determine whether PMI’s IQOS product meets the US Tobacco Control Act’s standard for MRTP claims. We examined whether PMI provided sufficient data showing tobacco users will not initiate with IQOS, that youth will not misperceive the MRTP-related claims being made concerning IQOS, and how youth perceive health risks associated with IQOS.ResultsPMI’s own studies failed to provide evidence that youth, including non-users and former users, will not find IQOS appealing, will not initiate use of IQOS and will not perceive these products as risk-free. Further, PMI did not refer to independent studies conducted among adolescents which could influence their conclusions. Finally, their studies suffered from design and implementation flaws and cannot be relied on to support the proffered claims.ConclusionPMI’s own data and available evidence from scientific studies conducted independent of the tobacco industry regarding how novel tobacco products are currently being marketed suggest that introduction of IQOS will result in adolescent and young adult non-users initiating tobacco use with IQOS and could also increase poly-use of IQOS along with other tobacco products.

scholarly journals Robustness of HPHC Reduction for THS 2.2 Aerosol Compared with 3R4F Reference Cigarette Smoke Under High Intensity Puffing Conditions

2020 ◽  
Vol 29 (2) ◽  
pp. 66-83
Author(s):  
Catherine Goujon ◽  
Samuel Kleinhans ◽  
Serge Maeder ◽  
Laurent Poget ◽  
Jean-Pierre Schaller
Keyword(s):  
Cigarette Smoke ◽  
High Intensity ◽  
Large Range ◽  
Tobacco Product ◽  
Mainstream Smoke ◽  
Cigarette Filter ◽  
Puff Volume ◽  
Multiple Regimes ◽  
Present Context ◽  
Health Canada

SummaryIn the absence of standards specific for testing the reduction robustness of the levels of harmful and potentially harmful constituents (HPHCs), the aerosol from the THS 2.2, a heated tobacco product, was compared with the mainstream smoke of the 3R4F reference cigarette over a broad range of machine-smoking regimes. The average reduction and the introduced concept of threshold limits of robust reduction were derived from HPHC concentrations, in mass per tobacco-stick normalized per total puff volume, to propose an alternative for the assessment of products where nicotine-adjusted yields would be inappropriate. In addition, this study explores the influence of 3R4F reference cigarette filter ventilation, and discusses the roles of temperature and precursors in the present context of robustness of HPHC reduction. Fifty-four HPHCs were analyzed under multiple regimes in THS 2.2 aerosol and 3R4F cigarette smoke. The average reduction of HPHC concentrations compared across all regimes characterized the robustness. Threshold limits of reduction of individual HPHCs were statistically determined across all regimes. The results observed under Health Canada Intense (HCI) and more intense regimes indicated that on average the reductions in HPHCs levels investigated in THS 2.2 aerosol were more than 90% and that the majority of the 54 HPHCs investigated in THS 2.2 aerosol showed more than 90% reduction. The robustness of THS 2.2 in maintaining the levels of reduction of representative HPHCs, whatever the puffing regime, can be quantified. The mass of HPHC per tobacco-stick normalized per total puff volume is a valuable approach to compare the robustness of the performance of a product over a large range of puffing conditions. Our findings will greatly complement the assessment for robustness of current and future similar products where classical approaches would present limitations.

scholarly journals Heated tobacco product regulation under US law and the FCTC

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s118-s125 ◽  
Author(s):  
Lauren Kass Lempert ◽  
Stanton A Glantz
Keyword(s):  
Tobacco Control ◽  
Scientific Evidence ◽  
Tobacco Product ◽  
Product Labelling ◽  
Tobacco Products ◽  
Control Laws ◽  
The Public ◽  
Philip Morris ◽  
Product Regulation ◽  
The Usa

Tobacco companies are marketing new ‘heated tobacco products’ (HTPs) composed of battery-powered holders, chargers and tobacco plugs or sticks. The non-tobacco HTP components have escaped effective regulation under many countries’ tobacco control laws because they are packaged and sold separately from the tobacco-containing components. In the USA, HTPs cannot be marketed unless the Food and Drug Administration determines that allowing their sale would be ‘appropriate for the protection of the public health’. Philip Morris International (PMI) is seeking permission to market its IQOS HTP in the USA with ‘modified risk tobacco product’ (MRTP) claims that it reduces exposure to harmful substances and is less harmful than other tobacco products. However, PMI has not submitted adequate scientific evidence required by US law to demonstrate that the product is significantly less harmful to users than other tobacco products, that its labelling would not mislead consumers, or that its marketing—with or without MRTP claims—would benefit the health of the population as a whole. Parties to the WHO Framework Convention on Tobacco Control (FCTC) must take measures to reduce tobacco use and nicotine addiction, and prevent false or misleading tobacco product labelling, advertising and promotions; the introduction of new HTPs must be assessed according to these goals. All components of HTPs should be regulated at least as stringently as existing tobacco products, including restrictions on labelling, advertising, promotion and sponsorship, sales to minors, price and taxation policies and smokefree measures. There is nothing in US law or the FCTC that prevents authorities from prohibiting HTPs.

scholarly journals Globalisation and income growth promote the Mediterranean diet

2004 ◽  
Vol 7 (7) ◽  
pp. 977-983 ◽  
Author(s):  
Anita Regmi ◽  
Nicole Ballenger ◽  
Judy Putnam
Keyword(s):  
Mediterranean Diet ◽  
Fruits And Vegetables ◽  
Market Access ◽  
Global Market ◽  
Potential Growth ◽  
Middle Income ◽  
The Usa ◽  
Growth Prospects ◽  
Packaged Food ◽  
The Impact

AbstractObjective:To examine global food demand patterns and how changing diets may stimulate demand for and trade of Mediterranean diet products.Design:Literature review. Trends in global and US food consumption patterns are examined and trade data are reviewed to evaluate the impact of changing diets on trade of Mediterranean diet products. Market access issues are also addressed briefly to highlight the role of policy in the trade of Mediterranean diet products.Results:Diets are shifting towards higher-value products such as meats, fruits and vegetables, and a wider array of packaged food products. Trade in these products has also grown in the past two decades, with several non-traditional importers and exporters becoming increasingly active in the global market.Conclusions:Income-driven demands for quality and variety are likely to increase the demand for Mediterranean diet products globally. While the middle-income countries appear to be the best growth prospects, the USA remains a potential growth market if these products can meet the growing consumer demand for variety, quality and convenience. Although consumer trends globally indicate growth in demand for Mediterranean diet products, the additional demand may not be reflected by a corresponding growth in trade. Trade in Mediterranean diet products continues to be hampered by higher than average trade barriers and high transportation costs for perishables.

scholarly journals Assessment of industry data on pulmonary and immunosuppressive effects of IQOS

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s20-s25 ◽  
Author(s):  
Farzad Moazed ◽  
Lauren Chun ◽  
Michael A Matthay ◽  
Carolyn S Calfee ◽  
Jeffrey Gotts
Keyword(s):  
Pulmonary Inflammation ◽  
Tobacco Product ◽  
Industry Data ◽  
Dual Use ◽  
Cigarette Smokers ◽  
Tobacco Products ◽  
Aerosol Exposure ◽  
Philip Morris ◽  
The Us ◽  
The Usa

IntroductionHeated tobacco products are being touted as novel reduced-harm tobacco products by tobacco companies. In the USA, Philip Morris International submitted a modified risk tobacco product (MRTP) application to the US Food and Drug Administration in 2016 in which it purports that its heated tobacco product, I-Quit-Ordinary-Smoking (IQOS), is associated with reduced harm compared with conventional cigarettes.MethodsWe reviewed Philip Morris International’s MRTP application to assess the pulmonary and immune toxicities associated with IQOS use in both animal and human studies.ResultsAmong rats exposed to IQOS, there was evidence of pulmonary inflammation and immunomodulation. In human users, there was no evidence of improvement in pulmonary inflammation or pulmonary function in cigarette smokers who were switched to IQOS.ConclusionIQOS is associated with significant pulmonary and immunomodulatory toxicities with no detectable differences between conventional cigarette smokers and those who were switched to IQOS in Philip Morris International’s studies. Philip Morris International also failed to consider how dual use and secondhand aerosol exposure may further impact, and likely increase, the harms associated with these products.

scholarly journals Evolving IQOS packaging designs change perceptions of product appeal, uniqueness, quality and safety: a randomised experiment, 2018, USA

2019 ◽  
Vol 28 (e1) ◽  
pp. e52-e55 ◽  
Author(s):  
Joseph G L Lee ◽  
Tiffany M Blanchflower ◽  
Kevin F O'Brien ◽  
Paige E Averett ◽  
Leslie E Cofie ◽  
...  
Keyword(s):  
Behavioural Intention ◽  
Visual Design ◽  
Tobacco Products ◽  
Perceived Safety ◽  
Philip Morris ◽  
Cigarette Brand ◽  
The Usa ◽  
Quota Sampling ◽  
Post Hoc ◽  
The Impact

BackgroundGlobally, the tobacco industry is promoting heated tobacco products. These products may represent a strategy to promote dual use of tobacco products. One product, IQOS from Philip Morris International, is being proposed in the USA for marketing as a less harmful product. The visual design of tobacco products can influence consumers by implying product characteristics. Thus, we sought to test the impact of IQOS packaging designs on cognitive, affective and behavioural intention responses.MethodsFrom existing IQOS packages used globally, we developed three IQOS packages that decreasingly linked the product to the Marlboro brand. In September to October 2018, we assigned participants randomly to one package in an online experiment. All participants (n=954) were US adults reporting current smoking and no colour blindness. The experiment used quota sampling to ensure diversity by gender, sexual orientation, race, ethnicity and education. Measures were informed by the Context of Consumption Framework. To assess differences in ratings, we conducted non-parametric Kruskal–Wallis tests with post hoc comparisons using Dunn’s test.ResultsWe found significant differences in cognitive indicators including appeal (H=6.87, p=0.03), uniqueness (H=15.68, p<0.01), brand equity–quality (H=122.35, p<0.01) and perceived safety compared with other tobacco products (H=14.27, p<0.01). Participants rated packages similarly on affective and behavioural intention measures. All were rated low for talking to others about the product and high for interest in trying with a coupon.ConclusionLinking or separating IQOS products with a well-established cigarette brand changes how adult smokers respond to the product. Regulators should consider the visual design of packaging.

scholarly journals Impact of 6-Month Exposure to Aerosols From Potential Modified Risk Tobacco Products Relative to Cigarette Smoke on the Rodent Gastrointestinal Tract

2021 ◽  
Vol 12 ◽  
Author(s):  
James N. D. Battey ◽  
Justyna Szostak ◽  
Blaine Phillips ◽  
Charles Teng ◽  
Ching Keong Tung ◽  
...  
Keyword(s):  
Cigarette Smoke ◽  
Heating System ◽  
Smoking Initiation ◽  
Tobacco Product ◽  
Intestinal Microbiome ◽  
Disease Pathogenesis ◽  
Tobacco Products ◽  
Microbiome Composition ◽  
Adverse Health Effects ◽  
The Impact

Cigarette smoking causes adverse health effects that might occur shortly after smoking initiation and lead to the development of inflammation and cardiorespiratory disease. Emerging studies have demonstrated the role of the intestinal microbiome in disease pathogenesis. The intestinal microbiome is susceptible to the influence of environmental factors such as smoking, and recent studies have indicated microbiome changes in smokers. Candidate modified risk tobacco products (CMRTP) are being developed to provide substitute products to lower smoking-related health risks in smokers who are unable or unwilling to quit. In this study, the ApoE–/– mouse model was used to investigate the impact of cigarette smoke (CS) from the reference cigarette 3R4F and aerosols from two CMRTPs based on the heat-not-burn principle [carbon-heated tobacco product 1.2 (CHTP 1.2) and tobacco heating system 2.2 (THS 2.2)] on the intestinal microbiome over a 6-month period. The effect of cessation or switching to CHTP 1.2 after 3 months of CS exposure was also assessed. Next-generation sequencing was used to evaluate the impact of CMRTP aerosols in comparison to CS on microbiome composition and gene expression in the digestive tract of mice. Our analyses highlighted significant gene dysregulation in response to 3R4F exposure at 4 and 6 months. The findings showed an increase in the abundance of Akkermansiaceae upon CS exposure, which was reversed upon cessation. Cessation resulted in a significant decrease in Akkemansiaceae abundance, whereas switching to CHTP 1.2 resulted in an increase in Lactobacillaceae abundance. These microbial changes could be important for understanding the effect of CS on gut function and its relevance to disease pathogenesis via the microbiome.

Sign in / Sign up

Export Citation Format

Share Document