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.

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.

Creating a market for IQOS: analysis of Philip Morris’ strategy to introduce heated tobacco products to the Australian consumer market

2020 ◽  
pp. tobaccocontrol-2020-056057
Author(s):  
Christina Watts ◽  
Suzan Burton ◽  
Becky Freeman
Keyword(s):  
Tobacco Control ◽  
Product Category ◽  
Tobacco Product ◽  
Tobacco Products ◽  
Control Laws ◽  
Study Approach ◽  
Corporate Strategies ◽  
Philip Morris ◽  
Legislative Changes

BackgroundPhilip Morris International has made efforts to expand the sale of its heated tobacco product, IQOS, into new domestic markets globally. In Australia, where heated tobacco products are prohibited, the company recently attempted to overturn Australian legislation in order to permit their sale. In light of this recent move, this study presents a case study of the company’s strategies to legalise and distribute IQOS in the Australian market.MethodsTo assess Philip Morris’ lobbying activities and corporate strategies, a case study approach was used by triangulating data from three sources: interviews with former Philip Morris employees, news articles reporting Philip Morris’ lobbying activities or plans for IQOS in Australia, and submissions to relevant government inquiries and reviews from 2015 to 2020.ResultsPhilip Morris has actively lobbied Australian policy-makers to overturn bans on nicotine-containing products. Information obtained from key informants and Philip Morris’ government submissions indicates that the company’s goal is for heated tobacco products in Australia to be regulated in a new product category, exempt from tobacco control laws. Informants revealed that Philip Morris was also working to establish a network of upmarket pubs, clubs and bars where they could sell IQOS once legalisation was achieved.ConclusionsPhilip Morris has strongly lobbied the Australian government to legalise heated tobacco products, while simultaneously making plans to sell IQOS at young adult-friendly premises such as bars, clubs and pubs if its proposed legislative changes are made. This case study provides valuable insights for other countries where Philip Morris may be replicating similar strategies to weaken tobacco control legislation.

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 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 Analysis of FDA’s IQOS marketing authorisation and its policy impacts

2020 ◽  
pp. tobaccocontrol-2019-055585 ◽  
Author(s):  
Lauren Kass Lempert ◽  
Stanton Glantz
Keyword(s):  
Public Health ◽  
Marketing Authorisation ◽  
Scientific Evidence ◽  
Health Impacts ◽  
Public Confidence ◽  
Independent Research ◽  
The Public ◽  
Philip Morris ◽  
Important Health ◽  
The Usa

BackgroundPhilip Morris Products SA (PMPSA) submitted a premarket tobacco application (PMTA) to US Food and Drug Administration (FDA) seeking an order permitting it to market IQOS in the USA. US law requires FDA to deny marketing authorisation if applicants fail to demonstrate that their product is ‘appropriate for the protection of the public health’. FDA issued a marketing order for IQOS in April 2019, which Philip Morris is using to promote IQOS outside the USA.MethodsWe analysed FDA’s Technical Project Lead Review and marketing order for IQOS, relevant law and guidance on PMTAs and independent research on the health impacts of IQOS.ResultsFDA found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic potential, some at higher levels than conventional cigarettes. PMPSA did not appropriately consider the health impacts of dual use, the product’s attractiveness to youth or data showing that consumers do not accurately perceive the addiction risks of IQOS. Despite FDA’s own scientists’ recommendations and independent research showing that IQOS presents serious risks to users including cytotoxic, genotoxic, hepatotoxic, cardiovascular and pulmonary risks, FDA concluded that IQOS is ‘appropriate for the protection of the public health’.ConclusionFDA’s decision allowing IQOS to be marketed in the USA disregarded valid scientific evidence and misapplied the public health standard mandated by law. This decision may have important health impacts, influence marketing IQOS outside the USA and erode public confidence in FDA’s future PMTA decisions.

scholarly journals Informing iQOS Regulations in the United States: A Synthesis of What We Know

SAGE Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. 215824401989882 ◽  
Author(s):  
Carla J. Berg ◽  
Yael Bar-Zeev ◽  
Hagai Levine
Keyword(s):  
United States ◽  
Tobacco Control ◽  
Tobacco Industry ◽  
The United States ◽  
Tobacco Product ◽  
Future Research ◽  
Tobacco Products ◽  
Philip Morris ◽  
International Collaborations ◽  
The U.S

The tobacco industry offers various products, including heated tobacco products (HTPs). Philip Morris International’s (PMI) “iQOS” has the greatest HTP market share, as well as research on its use and impact. iQOS was released in 2014 and is now in more than 40 countries. The U.S. Food and Drug Administration announced permission for PMI to sell iQOS in the United States in April 2019, and iQOS was launched in October 2019. Decisions pending its modified risk tobacco product (MRTP) application will occur subsequently. The U.S. regulatory efforts regarding iQOS could be informed by examining (a) Philip Morris USA other product marketing efforts and (b) the iQOS market in countries where it is available. This article briefly addresses these two points with extant literature and suggests that future research should address important gaps in what is currently known, including strategic international collaborations and research, which historically has been critical for advancing tobacco control globally.

scholarly journals Light and mild redux: heated tobacco products’ reduced exposure claims are likely to be misunderstood as reduced risk claims

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s87-s95 ◽  
Author(s):  
Lucy Popova ◽  
Lauren Kass Lempert ◽  
Stanton A Glantz
Keyword(s):  
Tobacco Product ◽  
Tobacco Products ◽  
Qualitative And Quantitative ◽  
Quantitative Studies ◽  
Philip Morris ◽  
The Us ◽  
The World ◽  
The Usa ◽  
And Behavior ◽  
Reduced Risk

IntroductionHeated tobacco products (HTPs) are being marketed in several countries around the world with claims that they are less harmful than combusted cigarettes, based on assertions that they expose users to lower levels of toxicants. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration (FDA) in 2016 seeking authorisation to market its HTPs, IQOS, with reduced risk and reduced exposure claims.MethodsWe examined the PMI’s Perception and Behavior Assessment Studies evaluating perceptions of reduced risk claims that were submitted to the FDA and made publicly available.ResultsQualitative and quantitative studies conducted by PMI demonstrate that adult consumers in the USA perceive reduced exposure claims as reduced risk claims.ConclusionThe data in the PMI modified risk tobacco product IQOS application do not support reduced risk claims and the reduced exposure claims are perceived as reduced risk claims, which is explicitly prohibited by the FDA. Allowing PMI to promote IQOS as reduced exposure would amount to a legally sanctioned repeat of the ‘light’ and ‘mild’ fraud which, for conventional cigarettes, is prohibited by the US law and the WHO Framework Convention on Tobacco Control.

scholarly journals PMI’s own in vivo clinical data on biomarkers of potential harm in Americans show that IQOS is not detectably different from conventional cigarettes

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s9-s12 ◽  
Author(s):  
Stanton A Glantz
Keyword(s):  
Drug Administration ◽  
Clinical Data ◽  
Tobacco Product ◽  
Tobacco Products ◽  
Potential Harm ◽  
Philip Morris ◽  
Detectable Difference ◽  
The Usa ◽  
Reduced Risk

IntroductionNew ‘heated tobacco products’ are being marketed in several countries with claims that they expose users to lower levels of toxins than conventional cigarettes which could be read as being less likely to cause health problems than conventional cigarettes. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration for permission to market its heated tobacco product, IQOS, with reduced exposure and reduced risk claims.MethodsAnalysis of detailed results on 24 biomarkers of potential harm in PMI studies of humans using IQOS compared with humans using conventional cigarettes.ResultsAmong American adults, there is no statistically detectable difference between IQOS and conventional cigarette users for 23 of the 24 biomarkers of potential harm in PMI’s studies. In Japan, there were no significant differences between people using IQOS and conventional cigarettes in 10 of 13 biomarkers of potential harm. It is likely that some of the significant differences are false positives.ConclusionDespite delivering lower levels of some toxins than conventional cigarettes, PMI’s own data fail to show consistently lower risks of harm in humans using its heated tobacco product, IQOS, than conventional cigarettes.

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.

The African American Tobacco Control Leadership Council: Advocating for a menthol cigarette ban in San Francisco, California

2021 ◽  
pp. tobaccocontrol-2020-056215
Author(s):  
Sarah D Mills ◽  
Carol O McGruder ◽  
Valerie B Yerger
Keyword(s):  
African American ◽  
Tobacco Control ◽  
San Francisco ◽  
Community Support ◽  
Control Policy ◽  
Tobacco Product ◽  
Lessons Learned ◽  
Menthol Cigarette ◽  
The Usa ◽  
Product Sales

The African American Tobacco Control Leadership Council (AATCLC) is an advocacy group that works to inform the direction of tobacco control policy and priorities in the USA. This article narrates the AATCLC’s work advocating for a comprehensive, flavoured tobacco product sales ban in San Francisco, California. Recommendations for tobacco control advocates and lessons learned from their work are provided. The article concludes by discussing conditions necessary to enact the policy. These include having a dedicated advocacy team, community support, a policy sponsor, and clear and repeated messaging that is responsive to community concerns.

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