• Philip Morris International (PMI) is increasingly moving into the ‘cessation space’.
• The US Food and Drug Administration denied PMI “reduced risk” status for its heated tobacco product IQOS. Nevertheless, PMI continues to push it as a cessation product, including in countries where it is currently banned.
• PMI uses misleading terminology when talking about IQOS use and “quitting”, and conflates its e-cigarettes and heated tobacco products (HTP), leading to confusion among the public, and potentially governments.
• PMI’s data for global IQOS use, used to promote the HTP and present it as a successful product around the world, are based in part on commercial data which is not publicly available and is skewed by data from Japan where e-cigarettes are banned.
• PMI’s ‘switching’ estimates are short term and downplay dual use of IQOS with cigarettes and the potential for initiation by non-smokers, including youth.
• There is very little evidence that IQOS is effective as a quit tool at the individual level or population level.
• Not all governments are prepared to accept IQOS as a cessation tool.

Background

Philip Morris International (PMI) has stated that it has a vision of a “smoke-free” future and that it intends to move its business away from combustible tobacco products entirely.¹² PMI envisages itself and its heated tobacco product (HTP), IQOS, as central in this vision. However, independent evidence does not support many of PMI’s claims about its product, including its claims about risk reduction and its effectiveness in helping people stop smoking. PMI’s commercial goal is not to stop people using tobacco altogether, but to ensure they continue to buy its products, including IQOS, and to increase the numbers of people doing so.³

PMI uses its own research and market data to produce estimates about users, IQOS usage, and the use of other tobacco products. While research on IQOS use is available on the PMI Science website and in some external publications (see below), PMI’s methodology for calculating its global estimates of IQOS use is not transparent. While there has been some independent research on the prevalence of HTP use (including IQOS), as of January 2023, PMI’s estimates for the total numbers of IQOS users globally were yet to be independently verified.

The Philip Morris company has a history of claiming that it promotes cessation.⁴ It even created its own, limited cessation programme called “QuitAssist”, launched in 2004 before PMI separated from parent company Altria.⁴⁵ This was not proven to be effective, but gave the company opportunities to engage with public health and government.⁴ (See also the page on Duke University and its connections to QuitAssist)

This page describes some of PMI’s more recent attempts to enter the ‘cessation space’ with IQOS. It then looks at relevant PMI statements from media interviews, press releases and industry publications, and the evidence it uses to support its claims, including that submitted to the US Food and Drug Administration (FDA). It summarises the independent, peer reviewed academic research relating to the use of IQOS, including prevalence, dual and poly use, and youth initiation. Finally, it describes the reaction from the governments of Australia, New Zealand and Mexico in 2020, in response to PMI’s attempts to introduce IQOS to their countries and frame them as cessation products.

What is cessation?

Use of the terms “cessation” and “quitting” varies, even within public health, and can be conceptualised in different ways, for example:

1. Quitting/cessation of smoked tobacco products
2. Quitting/cessation of any tobacco product
3. Quitting/cessation of any nicotine product

Products containing, or derived from, tobacco do not necessarily fall neatly into these categories, as definitions vary globally for the purposes of regulation and cessation.

The tobacco industry is able to take advantage of this diversity of opinion,⁶ and different attitudes towards harm reduction more broadly, to further its own commercial interests. For example, HTP manufacturers have gone to great lengths to frame HTPs as “smokefree” in order for potential consumers, governments and regulators to view them differently from combustible tobacco products, like cigarettes.³⁷ However, HTPs contain tobacco leaf and are therefore tobacco products.

PMI attempts to re-enter the ‘cessation space’ with IQOS

As governments increasingly struggle to fund their public health services and set up new smoking cessation (or ‘quit’) programmes, new opportunities have emerged for the tobacco industry to present itself as a solution to the problem it has created: getting consumers hooked on cigarettes, a deadly and addictive product.⁸⁹¹⁰¹¹

Proposed £1 billion fund for UK stop-smoking services

In February 2020, an investigation by The Guardian newspaper and Channel 4 TV’s Dispatches programme exposed PMI’s attempt to fund and run cessation services in the UK, in exchange for being able to promote IQOS.¹² Leaked documents showed that the company planned to create a GB£1 billion “tobacco transition fund” to be spent by UK health authorities, with GB£15 million to go to Public Health England to “facilitate switching”.¹² In exchange, PMI expected the lifting of restrictions on the advertising and marketing of IQOS and e-cigarettes. The Guardian reported that PMI encouraged a UK Member of Parliament, Kevin Barron, to present an (unsuccessful) bill proposing this in parliament in October 2018.¹²

Action on Smoking and Health (ASH) described this move by PMI as “completely unacceptable” and expressed concerns that the company’s ability to recruit a previously anti-tobacco MP to further its business interests was a sign of increasing normalisation of the industry in the UK.¹²¹³ Philip Morris’ statement to The Guardian indicated the range of its lobbying in the UK, in its attempt to co-opt existing cessation campaigns and undermine the ‘polluter pays’ principle proposed by ASH:¹³

“We have made this point time and time again to MPs, civil servants, local councillors, journalists and the broader public. What this story really shows is that Philip Morris has been consistent in its efforts to make smoke-free 2030 a reality.”¹²

Offered free IQOS to cessation services in New Zealand

In August 2019, a Radio New Zealand (RNZ) investigation reported that health officials had been lobbied by PMI to have IQOS included in public cessation programmes.¹⁴¹⁵ The company proposed supplying free IQOS devices in exchange for “community-based trials, data collection and monitoring”.¹⁴ It is not known if PMI were expecting the programmes to use IQOS exclusively, or alongside other evidence-based cessation tools. RNZ also reported that PMI had approached an advocacy group working with people on low incomes and had sold IQOS  to Maori groups at half price.¹⁴ New Zealand’s Director General of Health, Ashley Bloomfield, said that PMI was:

“doing its best on all fronts to … legitimise both its product and its role in being part of smoking cessation initiatives around the country.”¹⁴

Bloomfield instructed health officials to reject PMI’s approaches and reminded them of their obligation under FCTC article 5.3.¹⁴¹⁶

Funding cessation programmes through Foundation for a Smoke-Free World

PMI set up, and is the sole funder of, the Foundation for A Smoke Free World (FSFW). FSFW funds a number of cessation-related projects globally and, in 2020, appeared to be expanding this area of work. The Centre for Health Research and Education (CHRE), a private company run by an ex-employee of British American Tobacco (BAT) and a UK doctor, received grants from FSFW for cessation work in the UK, and to fund the scoping of work in India.¹⁷

In July 2020, FSFW published a country report on India.¹⁸ This covered research on cessation in India, mentioning nicotine replacement therapy (NRT) and “cessation medications”, and perceived gaps in provision, including the training of health care professionals and the establishment of tobacco cessation centres. In a section titled “Policies Prohibiting Tobacco and Harm Reduction Products in India”, it referred to India’s ban on e-cigarettes and other products and stated that “There is a growing demand for reduced-risk products globally, as well as evidence on e-cigarettes as a potential cessation tool, and it is important to consider the implications of this ban”.¹⁸ However, there appeared to be no further detail, or policy recommendations relating to cessation.

The Centre for Research Excellence: Indigenous Sovereignty and Smoking (COREISS) is a private company which presents itself as an independent scientific organisation whose stated goal is reducing tobacco-related harms among indigenous peoples. COREISS was funded by FSFW to “build a global center for smoking cessation and harm reduction in indigenous people” in New Zealand.¹⁷

For more information see the CHRE and COREISS pages. Details of other FSFW grants can be found on the FSFW grantees page. FSFW also funds a number of third-party organisations which campaign for a greater role, and fewer restrictions, on newer nicotine and tobacco products.  See for example the International Network of Nicotine Consumer Organisations (INNCO), Knowledge-Action-Change (K-A-C) and Pakistan Alliance for Nicotine and Tobacco Harm Reduction (PANTHR). PMI also directly funds Factasia.

The risks of using IQOS vs quitting

PMI portrays IQOS as a “reduced risk” product.³ In July 2020, the United States (US) Food and Drug Administration (FDA) granted PMI a “modified exposure” order but denied a “reduced risk” order, acknowledging that while IQOS reduces exposure to some potentially harmful chemicals it has not been shown to reduce the harm or risks of tobacco-related diseases.¹⁹

In July 2020, the WHO stated that there was a large gap in knowledge on HTPs, as they have not been on the market long enough to gather data on their health effects and broader impact.

“Conclusions cannot yet be drawn about their potential to attract new, young tobacco users (gateway effect), or the interaction in dual use with other conventional tobacco products and e-cigarettes”.²⁰

The Tobacco Control Research Group (TCRG) published a STOP briefing, and British Medical Journal editorial pointing out the potential for the misrepresentation of the FDA’s decision outside the US and advising that smokers trying to quit should use evidence-based methods, and only use HTPs “as a last resort”.²¹²²

Creating confusion around science is a long-standing tactic of the tobacco industry. For more information see Influencing Science

Redefining “quitting” as “switching”

Although PMI uses the word “quitting” in its public-facing media statements and interviews, it frames the concept in terms of  “switching”, “converting”, or “making the change” to IQOS, rather than quitting tobacco use entirely.²³²⁴ In its September 2020 “Scientific Update”, the word “quitting” appears once, compared to 20 uses of  “switch”²⁵ (“cessation” is only used in a summary of an academic study on e-cigarettes).

PMI has denied that the name “IQOS” stands for “I Quit Ordinary Smoking”.²⁶²⁷ However, Stanford University research on PMI’s IQOS marketing campaigns noted that even the use of the letter Q in the brand name reinforces the sense that the product is designed for ‘quitting’.²⁸

The WHO points out that consumers and regulators are likely to confuse or conflate the terms “switch” and “quit”, blurring the line between the two concepts, and helping the tobacco industry to position their HTPs as cessation aids (as well as arguing that they should be exempted from smoke-free regulation).⁸

PMI’s estimates of the numbers of IQOS users are widely reported in media coverage around the world, and there is evidence that they are also being used by PMI to lobby governments to encourage governments to open their markets to IQOS.²¹

For more information see PMI’s promotion of IQOS using FDA MRTP order

Conflating HTPs and E-cigarettes

PMI has also appeared to conflate HTPs and e-cigarettes (also known as electronic nicotine delivery systems, or ENDS) in its marketing. This has the potential to sow further confusion.²² For example, in its ‘Hold My Light’ campaign, it said that “similar to most e-cigarettes” HTPs produce a “a nicotine-containing vapour with much lower amounts of harmful chemicals than found in cigarette smoke”.³ This was described by Bath researchers as an attempt “to piggyback HTPs onto the relative acceptability of e-cigarettes as a form of harm reduction in some countries that permit their sale”.³

PMI had an e-cigarette called IQOS Mesh on the market in the UK until April 2020, when it appeared to have been withdrawn. PMI presented IQOS Mesh, now apparently rebranded as IQOS VEEV, as a product suitable for “e-vapor users, adult smokers considering the e-vapor category and dual users of e-vapor and heated tobacco products”. ²⁹³⁰ Consumers are likely to find this confusing, given the similar name to PMI’s HTP.

Researchers found that in New Zealand PMI conflated heated tobacco products (HTPs) with ENDS in its marketing material, with both products sold in dedicated stores called “IQ Vape”.³¹ Price promotions for IQOS products were “explicitly encouraging consumers to dual use an HTP with ENDS”.³¹ Changes identified in PMI’s marketing principles in 2019 indicated that IQOS HTPs can be promoted to users of other nicotine products, not just cigarette smokers, which could include former smokers using nicotine replacement therapy (NRT).³¹ The researchers also identified conflation in PMI’s descriptions of risk profiles, noting that, while PMI’s press releases argue that the public lacks clear information on products and risk:

“by conflating HTPs with ENDS, the company risks doing the very thing it says it opposes: propagating confusion and misinformation amongst consumers.”³¹

IQ Vape has also been registered by PMI as a trademark in New Zealand.³²³³³⁴ Europe,³⁵ and elsewhere.³⁶

While there have been randomised controlled trials (RCTs) using e-cigarettes to aid cessation,³⁷ at the time of publication there had been no RCTs testing the use of IQOS as a cessation aid.

PMI may also be conflating its products through business relationships. In Ireland, PMI joined the e-cigarette trade association Vape Business Ireland.³⁸ In 2021, PMI’s membership was listed on VBI’s website as IQOS, rather than the e-cigarettes brand Veev.³⁹ See also the page on UK retailer VPZ, which has a close financial relationship with Philip Morris Ltd, and markets IOQS HTPs in its stores as well as e-cigarettes.

• For more information on Mesh and VEEV and Vape Business Ireland, see E-cigarettes: Philip Morris International.

IQOS “Use”, “Switching” and “Conversion” – What Does PMI Mean?

The term IQOS “user” was used frequently in PMI annual reports and presentations to shareholders from 2018 onwards and refers to the “IQOS user base” when reporting its financial results.⁴⁰

PMI defines an IQOS “user” as an adult who has used the product for at least 5% of their total tobacco consumption for a period of 7 days.⁴¹ A “predominant user” would need to have used IQOS for at least 70% of their consumption and a “converted user” for 95%. It also has a broad category for those who use IQOS for between 5% and 70% of their consumption, which it calls a “situational user”.⁴¹

Conversion rates are a commonly used metric in tobacco research, referring to the rate of transfer from first use of a cigarette (commonly youth use) to regular, daily smoking.⁴² PMI’s definitions do not appear to be based on any classifications commonly used in prevalence and cessation surveys, and it does not explain its rationale for how it developed its percentage bands. While the bands may serve to categorise users of IQOS, they do not predict cessation success or equate to the reduction of harm.

In February 2020, PMI stated that 14 million people were using IQOS. According to PMI, 10 million IQOS users (71% of the total) had stopped smoking and “switched” to IQOS, and an estimated 4 million were “in various stages of conversion” (i.e. still smoking cigarettes).⁴³PMI regularly updates these figures in its public statements. In September 2020, CEO Andre Calantzopoulos gave a figure of 11.2 million as having ‘switched’ to IQOS.⁴⁴ By the end of 2021, PMI stated that this had risen to 21.2 million.⁴⁵

PMI states that its “aspiration” is for the number of smokers switching to IQOS to exceed 40 million by 2025.⁴⁶

What are its estimates based on?

It is not clear how PMI calculates its user estimates. In its presentations and corporate reports, it states that they are based on a combination of “PMI financials or estimates, IQOS user panels and PMI market research” (see Image 1 below).⁴⁷Information on IQOS sales and revenue from IQOS (but not profit) is reported in company statements, but PMI does not share the raw data from its user panels or market research.

Image 1: PMI’s estimates of IQOS users 2018- 2019 (Source: PMI, 2019 Fourth Quarter and Full Year Results presentation, 6 February 2020)

In 2019, PMI said that it would conduct a series of annual surveys to estimate the prevalence and use patterns of IQOS and other nicotine products in Germany, Italy and part of the UK.⁴⁸ PMI stated that “the results of the first year data analysis are expected to be available by June 2019”. As of January 2023, these results did not appear to be publicly available.

The “PMI Science” website presents some findings relating to the use of IQOS based on surveys conducted in Japan between 2016 and 2018.⁴⁹⁵⁰

The problem with “conversion”

PMI stated in a 2018 presentation to shareholders that “High full conversion rates for an RRP [Reduced Risk Product] product [sic] are of fundamental importance” to consumers, the company and regulators as it “underscores a higher potential to meaningfully improve public health, as [IQOS] has a demonstrated ability to switch current smokers to proven better alternatives than cigarettes”.⁵¹

However, PMI’s estimates for those who have “converted” to IQOS are based on a seven day assessment only,⁵² which limits the ability to generalise the findings as a reflection of sustained behavioural change. It is likely that the number of people who use IQOS exclusively is lower than PMI’s estimates.³ PMI’s statements are based on the assumption that current dual users of tobacco and IQOS will all give up smoking cigarettes, and that the process of “conversion” will not be reversed.³⁵³

PMI does not systematically publish raw data on the quit intentions of its users. Prior to the EU menthol ban, Philip Morris Ltd (PMI’s UK subsidiary) reported that 15% of UK consumers would try to quit in response to the ban, while over 50% would consider switching to IQOS “once made aware of this option”. It appears that this survey involved showing participants the IQOS device, but it is not known if they were shown other HTPs, e-cigarettes, smokeless tobacco or medical cessation tools, such as nicotine replacement therapy (NRT).⁵⁴ This finding has not been independently verified and other survey data does not support PMI’s claims. (For more details see Menthol Cigarettes: Industry Interference in the EU and UK)

Dual and poly use

Evidence suggests even low levels of ongoing smoking can be deadly.⁵⁵ Thus, if HTPs are to have a potential public health benefit, they must not only reduce the  risk of harm and disease compared to cigarettes and other smoked products (currently unproven), but also be used by smokers exclusively, not just ‘most of the time’.

Yet, there is emerging independent evidence of considerable dual and poly use in countries where PMI says that IQOS is helping smokers to quit cigarettes. Multiple independent studies amongst have found many HTP users also concurrently use other tobacco and nicotine products, particularly cigarettes.^{56575859606162} In two of these studies, the authors note their findings suggest HTPs may serve as “complements” to cigarettes rather than an aid to quitting them.⁵⁶⁵⁷

These patterns of dual and poly use are confirmed by PMI’s own evidence. For example, 2017 and 2019 conference posters based on PMI’s surveys in Japan identify, yet downplay, significant dual and poly use of IQOS, cigarettes and other nicotine products. ⁴⁹⁶³

Apart from this not being a representative sample of the global population, e-cigarettes are banned in Japan, meaning that IQOS has little competition from other products. As the FDA noted:

“Consumers may be more likely to try using IQOS if non‐cigarette tobacco products such as nicotine‐containing e‐cigarettes are not readily available”.¹⁹

In its review, the FDA created its own chart based on PMI’s perception and behaviour studies and definitions (image 2 below). This showed that across five countries, significantly more people also used cigarettes (dual use) or reverted to cigarettes, than exclusively, or even predominantly, used IQOS.¹⁹

Image 2: FDA chart showing dual use, based on PMI’s data (Source: FDA)¹⁹

Academic review by McKelvey et al. found that PMI’s consumer perception and behaviour studies were fundamentally flawed in multiple ways: findings were extrapolated from a diary task to the whole sample, when only half of the participants had completed it; studies did not count use of other tobacco products, only cigarettes and IQOS; studies were limited to a 4-6 week period, when HeatSticks were provided for free (giving a price advantage and potential bias, meaning that the results were not representative of smokers or HTP users); and they did not allow sufficient time to identify how many IQOS users might “switch back” to cigarettes.⁶⁴ In addition, the authors stated that PMI had mis-represented its own finding around participants’ quit intentions and downplayed the likelihood of dual or poly use.⁶⁴

Euromonitor International (which receives project funding from the Foundation for a Smoke Free World and PMI) published a report in May 2020, which included some general findings on nicotine use from surveys it conducted in 2019 and 2020.⁶⁵ In part, this survey was designed to “understand the extent and nature of dual and multiple formats”.⁶⁵ The report noted that the HTP market is still relatively small, and that dual and poly use is most common among smokers who also use e-cigarettes and/or other products (which were not specified in this report). It also stated that in the case of HTPs, only 15% of users reported that they were planning to quit completely in the next year, and that this was “the smallest proportion of consumers of any category”.⁶⁵ Euromonitor suggests this is due to the “immaturity” of the HTP category compared to other tobacco and nicotine product categories, such as e-cigarettes.⁶⁵

Another Euromonitor report from April 2020, based on its nicotine survey, stated that around 20% of e-cigarette users planned to move to HTPs (up from 18% in 2019) and around 30% of HTP users planned to move to e-cigarettes. Given the large size of the e-cigarette market this would lead to a significant “net gain for heated tobacco”.⁶⁶

For information on the global HTP market see Heated Tobacco Products

PMI is careful in public statements not to refer to IQOS users as “smokers”, even when they also smoke cigarettes. Stanford University researchers have pointed out that dual use of cigarettes and IQOS, where smoking is not allowed for example in “IQOS Friendly Places”, may in practice “serve to deepen nicotine addiction and make cessation less probable”.²⁸

HTPs may attract non-smokers

PMI also downplays data on non-smokers who start using IQOS. In work based on its Japanese surveys, PMI states that “initiation and re-initiation of tobacco use with IQOS was minimal in both surveys and years” but does not explain how these figures were derived.⁴⁹ PMI’s studies have actually found up to 2% of registered Japanese IQOS users were not nicotine or tobacco users when they started using IQOS.⁶⁷⁴⁹ Further, up to 6% of non-smokers and up to 15% of former smokers expressed an intention to use IQOS in PMI’s Japan and US surveys.⁶⁸⁶⁹ None of these studies have been published in peer-reviewed journals.

There is some evidence emerging that HTPs may be attractive to those who have never smoked cigarettes, including young people.⁷⁰ While there is currently little evidence of a potential ‘gateway effect’ (i.e. people who don’t smoke or use nicotine products start using HTPs and then move onto conventional cigarettes), any tobacco or nicotine product uptake would clearly lead to an increase in harms to health.³⁷ Research from Italy (a country where HTPs were introduced at a favourable tax rate, and a key IQOS market) found that 45% of Italy’s 740,000 IQOS users, and over half of the 1.2 million people who were expressed an intention to try IQOS, were people who had never smoked.⁷¹⁷² This finding was supported by research from South Korea, which found that HTPs were likely to be attractive to youth who had not previously used any tobacco products.⁷³ The FDA noted that:

“the currently available evidence suggests that youth uptake of IQOS is currently low in countries where it has been measured. However, given that IQOS is still a relatively new product, the uptake and use patterns among youth in these markets, or any market that may start selling IQOS, is unclear”.¹⁹

Its marketing authorisation for IQOS in the US requires PMI to conduct post-market assessments to “ensure that youth exposure to tobacco marketing is being minimized”.¹⁹

Analysis of surveys conducted in Canada, England and the US, published in 2020, also found that non-smokers were interested in trying the product.⁷⁴

IQOS rejected as a cessation tool

There is very little evidence that IQOS is effective as a quit tool at the individual level or population level. A 2022 Cochrane review of the evidence on HTPs for cessation concluded:

“Heated tobacco probably exposes people to fewer toxins than cigarettes, but possibly more than not using any tobacco. Falls in cigarette sales appeared to speed up following the launch of heated tobacco in Japan, but we are uncertain whether this is caused by people switching from cigarettes to heated tobacco”.⁷⁵

New Zealand

When instructing public health officials to reject PMI’s offer of free IQOS in August 2019, the Director-General of Health stated that “the health sector does not share the same goals or aspirations of this industry”.¹⁶ He also referred to PMI’s funding of FSFW, and discouraged engagement with COREISS, stating that “there is a range of alternative sources of information and advice on smoking cessation and the possible use of vaping products to support cessation, including for Māori”.¹⁶

Australia

Despite intense lobbying by PMI to allow the sale of IQOS, in August 2020, the Australian government’s Therapeutic Goods Administration (TGA) rejected the sale of HTPs in Australia.⁷⁶⁷⁷.

The TGA found that PMI’s assertion that smoking rates in Australia had “stagnated” was inaccurate, and that rates were in fact continuing to decline. In addition to uncertainty over nicotine levels and general health risks (which included PMI’s own research findings), the TGA also highlighted the concern that HTPs might still attract people who had never smoked, including youth: “there would be no ability to restrict the supply of HTPs to smokers seeking to quit”.⁷⁶

In Australia, nicotine products, including HTPs, are available via a medical prescription for smoking cessation. The TGA concluded that as a consequence, there was no justification to introduce “a new nicotine product for non-therapeutic use”.⁷⁶

Mexico

In September 2020, the Mexican Ministry of Health reaffirmed the ban on the import of HTPs, made clear that IQOS had not been granted any form of reduced risk status in Mexico and stated that it did not support its use as a tool to stop smoking.⁷⁸ For more information see: Heated Tobacco Products

Why does this matter?

TCRG researchers have stated that until the relative health risks are determined, HTPs, including IQOS, have no public health role:²²

“There is currently no evidence that IQOS helps smokers quit. Smokers wishing to quit should use products shown to be safe and effective in line with national and international guidance.”²¹⁷⁹

PMI’s attempts to establish or take over cessation programmes could have a damaging effect on public health. Writing about Philip Morris’s historical efforts, MacDaniel et al concluded that:

“Such endeavors have the potential to inflict real harm by competing with more effective programs and by helping to maintain a tobacco-favorable policy environment. If PM truly wanted to support cessation, it could drop legal and other challenges to public policies that discourage smoking.”⁴

In 2023, the same statement can be applied to PMI.

Relevant Links

• Addiction at any cost: Philip Morris International Uncovered, Stopping Tobacco Organisations and Products/Tobacco Control Research Group, 2020
• STOP/TCRG, FDA does not rule that IQOS reduces tobacco-related harm, yet PMI still claims victory, Issue brief, July 2020
• WHO statement on heated tobacco products and the US FDA decision regarding IQOS, July 2020

TobaccoTactics Resources

• Harm Reduction
• Heated Tobacco Products
• Newer Nicotine and Tobacco Products: Philip Morris International
• PMI Promotion of IQOS Using FDA MRTP Order

TCRG Research

• Tobacco industry messaging around harm: Narrative framing in PMI and BAT press releases and annual reports 2011 to 2021, I. Fitzpatrick, S. Dance, K. Silver, M. Violini, T.R. Hird, Frontiers in Public Health, 18 October 2022. doi:10.3389/fpubh.2022.958354
• Corporate communication of the relative health risks of IQOS through a webchat service, S. Braznell, J.R. Branston, A.B. Gilmore, Tobacco Control, Online First: 03 March 2022. doi: 10.1136/tobaccocontrol-2021-056999
• PMI New Zealand conflates IQOS heated tobacco products with electronic nicotine delivery systems, L. Robertson, J. Hoek, K. Silver, Tobacco Control Published Online First: 19 November 2021. doi: 10.1136/tobaccocontrol-2021-056964
• US regulator adds to confusion around heated tobacco products, A.B. Gilmore, S. Braznell, BMJ, 2020;370:m3528
• Understanding the emergence of the tobacco industry’s use of the term tobacco harm reduction in order to inform public health policy, S. Peeters, A. Gilmore, Tobacco Control, 2015,24(2):182-189

For a comprehensive list of all TCRG publications, including research that evaluates the impact of public health policy, go to TCRG publications.

References

The post PMI’s IQOS: Use, “Switching” and “Quitting” appeared first on TobaccoTactics.

Background

I-Com was founded in 2005 by, what it describes as, a collection of “scholars, professionals and managers” with the objective “to promote debates and analyses on competitiveness concerning innovation, in the Italian, European and international politico-economic contexts”.⁸² The think tank focuses on areas such as digitalisation, energy, innovation, health and institutions.⁸²

Relationship with the Tobacco Industry

As of 14 October 2020, I-Com listed British American Tobacco’s (BAT) EU Office as a partner on its website. On 14 October, other partners included Amazon, European Energy Retailers, Enel, Google, Huawei, Johnson and Johnson, MSD, and Qualcomm.⁸³

As of 3 November 2020, BAT was no longer listed as a partner.⁸⁴

The think tank began publishing content on tobacco and harm reduction after World No Tobacco Day on 31 May 2020. I-Com joined the European Commission’s public consultation on ‘Europe’s Beating Cancer Action Plan’ with the intention of “[contributing] to the EU decision-making process towards the adoption of the European Cancer Plan”.⁸⁵ The public consultation provided an opportunity for citizens, researchers, policy-makers and other stakeholders to input opinions on best practices for addressing cancer.⁸⁵

In May 2020, I-Com published an article outlining its contribution to the public consultation. In regard to harm reduction, the article states:⁸⁵

• “a harm reduction strategy for smokers should be defined, including the use of alternative nicotine delivery products such as e-cigs. Regulation needs to balance risks and benefits with the aim of reducing smoking through the supply of behavioural support and evaluating the impact through constant monitoring”
• “a successful cancer plan must be committed to risk reduction and improving daily assistance through continued efforts to decrease smoking rates by preventing the uptake of smoking and promoting cessation through harm reduction plans”

In July 2020, I-Com published a factsheet titled “Cancer Prevention: Better Lifestyle Policies – A Priority for the European Union”.⁸⁶⁸⁷ The think tank called for public authorities to promote and “encourage harm reduction strategies”.⁸⁶⁸⁷ The factsheet provided an analysis of stakeholder submissions to the public consultation on Europe’s Beating Cancer Plan. It revealed that “nearly 20% of contributions supported the definition of harm reduction plans for alcohol and tobacco” and “one in every six recommended policies which encourage the use of reduced risk nicotine products by smokers, such as e-cigarettes”.⁸⁶

In September 2020, I-Com organised a roundtable discussion on Europe’s Beating Cancer Plan involving MEPs. The open platform brought together 50 participants to discuss how the European Parliament can play a role in contributing to the Beating Cancer Plan and best practices for cancer prevention. Speakers at the roundtable included Clive Bates, former Director of ASH, and Konstantinos Poulas, professor at the University of Patras.⁸⁸⁸⁹

Following the roundtable, the think tank recommended “increasing the availability of smokeless tobacco products” as a means of minimising harms.⁸⁸⁸⁹

People

• Stefano Da Empoli – President and Principal Policy Analyst⁸²
• Mattia Ceracchi – Head of EU Affairs⁸²
• Eleonora Mazzoni, Head of Innovation Area ⁸²

Use of Think Tanks by the Tobacco Industry

The tobacco industry has a history of collaborating with think tanks around the world, to assist in indirect lobbying. These think tanks provide an echo-chamber for key messages from the industry. For more information on think-tanks and allies of the tobacco industry around the world, see Think tanks and Third party techniques.

Tobacco Tactics Resources

• British American Tobacco
• Think Tanks
• Third Party Techniques
• Harm reduction

References

The post Institute for Competitiveness (I-Com) appeared first on TobaccoTactics.

For more information on the Foundation, see our pages on the Foundation for a Smoke-Free World and its Centres of Excellence.

Relationship with the tobacco industry

Both CoEHAR and its founder Polosa have significant links to the tobacco industry. Polosa has disclosed that he has worked as a consultant to British American Tobacco. He has also previously received funding from Philip Morris International, Philip Morris USA, JUUL Labs Inc. and collaborated with tobacco industry scientists. More information can be found on our page on Riccardo Polosa.

CoEHAR funded by Foundation for a Smoke-Free World

In 2018, CoeHAR was given two grants worth US$205,805 in total from the Foundation for a Smoke-Free World (FSFW), an ostensibly independent scientific organisation aimed at “accelerating the end of smoking”, which is solely funded by Philip Morris International (PMI).⁹² The official grantee named in FSFW’s 2018 tax return was ECLAT SRL, “a spin off of the University of Catania”.⁹³ The purpose of the first grant was to set up the Centre of Excellence for the Acceleration of Harm Reduction (COEHAR), and the other was to “accelerate and improve smoking precision and detection rate of monitoring the smoking episodes by using the smokebeat technology”.⁹² The first grant was awarded on 30 May 2018 to the value of US$130,559 and the second grant was awarded on 28 September 2018 and worth US$75,246. The tax return also shows that at the end of 2018, US$22,810 in grant money was still to be paid to the Centre.⁹²

In 2019, CoEHAR received an additional US$8,036,493 from FSFW to:⁹⁴

“act as a hub for the global coordination of scientific research projects for advancing the science of tobacco cessation and harm reduction.”

Other details of ECLAT projects were given on the FSFW tax return: ECLAT executes 5 primary project types (1) cohort and clinical studies; (2) product characterisation ; (3) wellness studies; (4) technological innovation and (5) knowledge sharing and capacity strengthening”.⁹⁴

The FSFW 2019 tax return also showed that it had committed a further US$22,928,186 in funding to CoEHAR in the future.⁹⁴ In 2020 CoEHAR received US$88,551 from FSFW.⁹⁵ In 2021, its grant value was increased to US$1,083,565,⁹⁵ and in 2022 increased again to US$2,822,437.⁹⁶

As of February 2021, the University of Catania and CoeHAR have not disclosed the FSFW funding for CoEHAR on their respective websites.⁹¹⁹⁷ Find out more about the Foundation’s Centres of Excellence.

CoEHAR describes itself as a consortium with partners including Eclat (the organisation through which CoEHAR receives its grant funds from FSFW)⁹⁸⁹⁹, the ‘Center for Tobacco Prevention and Treatment’ (CPCT) and the Italian Anti-Smoking League (LIAF).¹⁰⁰

CoEHAR also lists seventeen ‘international partners’ which include other FSFW grantees COREISS and the NOSMOKE Institute at Patras Science Park, and universities in Iran, Morocco, Serbia, Romania, Bangladesh, USA, Oman, Poland, Russia, India and the UK.¹⁰⁰

People

The CoEHAR staff page states it employs a group of researchers and administration staff from the University of Catania. The staff at CoEHAR work in a variety of departments at the university such as Clinical and Experimental Medicine, Legal Sciences, Biomedical and Biotechnological Sciences and the Centre for Tobacco Prevention and Treatment.¹⁰¹  Riccardo Polosa is the founder of CoEHAR.¹⁰¹ Polosa was also the Director of CoEHAR up until January 2020 when he was replaced by Giovanni Li Volti, who signed a four year contract with the Centre.¹⁰²¹⁰¹ Giovanni Li Volti is also a professor at the University of Catania in the Department of Biomedical and Biotechnological Sciences.¹⁰³

Outputs

CoEHAR have launched some of their Foundation-funded research projects, including:¹⁰⁴

• CoEHAR launched ‘Catania Conversation’, a project which aims to connect journalists, scientists and opinion leaders to work together and fill the “communication gaps” around tobacco harm reduction.¹⁰⁵
• In November 2019, CoEHAR launched “REPLICA”, an initiative looking to replicate studies on e-cig and HTP to independently validate industry results.¹⁰⁶¹⁰⁷ At the first international training Rector Professor Francesco Prioli, head of the Physics & Astronomy Department at the University of Catania, outlined the study’s aim: “Replica will validate the independence of the results of science from any type of external influence”.¹⁰⁷¹⁰⁸ In February 2020, Serbian national television broadcast a tour of CoEHAR’s research laboratory at the University of Kragujevac with Giovanni Li Volti. Serbia is one of the six partner countries participating in the Replica project which aims to research the damage caused by conventional cigarette smoke. In addition to Italy and Serbia, the other counties participating are the US, Russia, Oman and Indonesia.¹⁰⁹
• In October 2019, CoEHAR launched the International Summer School on Project Management (ISPM) which aimed to support project management skills of young professionals and students.¹¹⁰ Riccardo Polosa and Francesco Purrello, the Director of the Department of Clinical and Experimental Medicine at the University of Catania, are on the ISPM Committee board.¹¹¹

Polosa has published a huge volume of research papers, some in collaboration with colleagues from CoEHAR. Some fail to disclose the links between CoEHAR, FSFW and PMI.¹¹² The following are several examples of research publications in which Polosa failed to disclose that he is funded by FSFW.

• A 2020 article titled Smoking and SARS-CoV-2 Disease (COVID-19): Dangerous Liaisons or Confusing Relationships? critiques a study conducted by Brake and colleagues concerning the relationship between smoking and COVID-19. Polosa and his colleagues argue the original study is highly inaccurate in stating that e-cigarettes are not “safer” than traditional cigarettes.¹¹³
• Another article published in 2020 critiques a study conducted by Reynales-Shigematsu and colleagues concerning the public health impact in Mexico of combustion-free electronic nicotine delivery systems (ENDS). Polosa and his colleagues argue that the original study does not recognise the utility of e-cigarettes as a harm reduction alternative for improving smoking cessation.¹¹⁴¹¹⁵
• A 2019 paper identified as an issue the lack of anti-smoking treatments for e-cigarette or dual users. The article outlines the trial steps to test the efficacy of varenicline, combined with 12 weeks of counselling, on e-cigarette users willing to quit. As of the article publication date, the study proposed in the article had not taken place.¹¹⁶
• A study published in 2019 evaluated different smoking cessation treatments to estimate their efficacy. Its findings include that different strategies, such as using e-cigarettes, improves the success of smoking cessation.¹¹⁷
• In 2018, a CoEHAR-affiliated article promoted research on how virtual reality can increase smoking cessation in young adults.¹¹⁸

The conflict of interest statement in the following articles, which are co-authored by Polosa, do state that the CoEHAR has received a grant from the FSFW to develop research projects. A 2020 article, titled “A Report on Smoking Detection and Quitting Technologies”, evaluated the usability and effectiveness of different available smoking detection and quitting technologies designed to encourage smoking cessation and included the following statement: “Produced with the help of a grant from the Foundation for a Smoke-Free World, Inc”.¹¹⁹ In 2019, Polosa and colleagues published an editorial piece entitled “Health Impact of electronic cigarettes and heated tobacco systems“ and a narrative review of e-cigarette aerosol emissions and respiratory health, which both promote the relative safety and reduced public health impacts of using tobacco harm reduction products such as e-cigarettes in comparison to conventional cigarettes.¹²⁰¹²¹

Events

• The CoEHAR Catania Conversation initiative hosts an online masterclass webinar on 29 May 2020, which is World No Tobacco Day.¹⁰⁵
• On 3 March 2020, CoEHAR partnered with the Italian Anti-Smoking League (LIAF) to participate in a seminar during ‘Scientific Culture Week’ at the University of Catania.¹²² After many years as President of LIAF, Polosa now serves as LIAF’s Chief Scientific Advisor.¹²³
• In September 2019, the winners of the Conrad Challenge, which is funded by FSFW, travelled to CoEHAR as part of their grand prize. The group of students from the US were guests at CoEHAR for three days and followed a structured visitor programme learning about innovation, technology and excellence at the centre.¹²⁴
• On 24 June 2019, a conference, led by Riccardo Polosa, announced the CoEHAR’s nine new smoking cessation and harm reduction research projects. These were: Smoke Free Sicily, Food Recognition Tech, Smile Study, EU-PATH, International Summer School on Project Management, Replication Studies, Long-Term Health Effect Study, Diasmoke 2.0 and In Silico Science.¹²⁵. Speakers at the event included Dr Derek Yach, the President of the Foundation for a Smoke-Free World.¹²⁵ The nine CoEHAR initiatives are being funded by a grant from the Foundation.¹²⁵

Lobbying

• In July 2022 CoEHAR members signed a letter in opposition to the Government of Bangladesh’s amendment to the Smoking and Using of Tobacco Products (Control) Act.¹²⁶ The amendment would prohibit smoking in public places, ban tobacco company Corporate Social Responsibility and prohibit sale of e-cigarettes.¹²⁷ The letter urged the government “not to prohibit smoke free nicotine-based alternatives to combustible cigarettes” and to “encourage the migration from high-risk to low-risk products”.¹²⁶
• In August 2022 CoEHAR members, including Riccardo Polosa , sent a similar letter to the government of Malaysia, also urging them “not to prohibit smoke free nicotine-based alternatives to combustible cigarettes”.¹²⁸ The Malaysian Tobacco and Smoking Products Control Bill proposes prohibiting the sale and possession of tobacco or nicotine products to anyone born after 1 January 2007.¹²⁹
• Riccardo Polosa successfully lobbied for vape shops to remain open in Italy during the COVID-19 lockdown.¹³⁰
• In September 2019, Riccardo Polosa coordinated the first CEN European Standards Committee round table meeting in Catania. Polosa lobbied for tight quality and safety standards for additions to e-cigarette liquids and their design to ensure the safety of the European Vaping Products Market.¹³¹
• In August 2019, Riccardo Polosa travelled to New Delhi to urge the Indian Ministry of Health to reconsider the recommendation of a ban on e-cigarettes in all states. A team of scientists, led by Polosa, explained that the government should instead integrate the promotion of “reduced harm” products alongside tobacco control measures and withdraw their recommendation to ban e-cigarettes.¹³²

Relevant links

• CoEHAR website

TT resources

• Foundation for a Smoke-Free World
• Foundation for a Smoke-Free World Grantees
• Foundation for a Smoke-Free World Centres of Excellence
• Harm Reduction
• E-cigarettes
• Riccardo Polosa

References

The post Centre of Excellence for the Acceleration of Harm Reduction (CoEHAR) appeared first on TobaccoTactics.

The FSFW is an ostensibly independent scientific organisation aimed at ‘accelerating the end of smoking’ which is solely funded by Philip Morris International (PMI). The Foundation has asserted that by funding these research centres it “aims to develop the next generation of leaders and institutions that will accelerate the end of smoking”.¹³³

Two of the research centres have direct links to the tobacco industry. Visit the Foundation Grantees page for full details on all its grants.

New Zealand: Centre of Research Excellence on Indigenous Sovereignty & Smoking

The first research centre funded by the FSFW was the Centre of Research Excellence: Indigenous Sovereignty & Smoking (COREISS) based in Auckland, New Zealand. COREISS was set up by Dr. Marewa Glover, a Māori public health academic and advocate for social justice and tobacco harm reduction. COREISS’ mission is to “support indigenous aspirations to flourish as individuals, families, tribes and nations who are recognized as sovereign people”.¹³⁴ FSFW’s grant of US$978,449 was awarded to COREISS on 30 May 2018 and aimed at building “a global centre for smoking cessation and harm reduction in indigenous people”.⁹² As of May 2019 only US$489,225 had been paid out.⁹² By August 2019, this total had risen to US$1,798,829, with US$7,320,042 committed in future funding.⁹⁴ The first FSFW-funded COREISS output was a report published in May 2019 and called “Quantifying Māori spend on tobacco, alcohol & gambling”.¹³⁵ It summarised the tobacco, alcohol and gambling tax burden of the Māori population. Glover has long claimed that tobacco tax increases unfairly target Māori and Pasifika groups,¹³⁶¹³⁷ “take money from the poor”,¹³⁶ do not work,¹³⁸ and push smokers to the illicit market.¹³⁶ Some of these claims are arguments echoed by the tobacco industry.

Contrary to Glover’s claim, tobacco tax is a well-evidenced and effective tobacco control policy tool. (See also: Price and Tax). A 2019 World Bank report concluded that tobacco taxes have effectively reduced smoking prevalence in countries with various levels of economic and institutional development and only play a minor role in illicit trade.¹³⁹

Glover has been criticised by NGO Hāpai Te Hauora Māori Public Health and a group of Indigenous public health experts from New Zealand, Canada, US and Australia for accepting (albeit indirectly) tobacco industry money and thereby legitimising the FSFW and PMI.¹⁴⁰ Writing in Tobacco Control, the Indigenous health leaders state that the tobacco industry will “use the Foundation to meet its agenda which is in stark contrast to the health and well-being agendas of Indigenous peoples” and that “co-optation of Indigenous culture” must be resisted. They add that the tobacco industry has a history of exploiting and appropriating Indigenous culture to sell and promote commercial tobacco. They also assert that the debate around next generation products and their potential to improve Indigenous health should be led by Indigenous peoples and not be influenced by organisations linked to the tobacco industry.¹⁴⁰

Italy: Center of Excellence for the Acceleration of Harm Reduction (CoEHAR)

In May 2018 the FSFW awarded US$130,559 to ECLAT SRL, “a spin off of the University of Catania”,¹⁴¹ towards the “center of excellence for the acceleration of harm reduction (CoEHAR)”.⁹² By May 2019, this total had risen to US$8,036,493, with US$22,928,186 committed in future funding by FSFW.⁹⁴

The CoEHAR was set up in March 2018 by tobacco harm reduction advocate Riccardo Polosa, who has a history of undertaking consultancy work for the tobacco industry. For example, in 2017 he was awarded a research grant of nearly a million Euros from PMI to investigate its heated tobacco products (HTP).¹⁴² In 2018, he consulted for British American Tobacco (BAT) on three clinical trials for HTP and e-cigarettes, via Swiss-based consultancy firm Health Diplomats led by Delon Human.¹⁴³ For more information, go to our pages on CoEHAR and Riccardo Polosa.

Scotland: Centre of Excellence in Behaviour Research Related Smoking Cessation

The FSFW awarded US$96,063 in May 2018 to the Centre for Substance Use Research (CSUR), based in Glasgow “to develop a centre of excellence in behaviour research related to smoking cessation”.⁹² As of May 2019 US$92,941 had been paid out.⁹² The Centre did not receive further funding from FSFW in 2019.⁹⁴

Neil McKeganey founded the Centre for Drug Misuse Research at the University of Glasgow in 1994 to carry out research on Scotland’s drug problem. Its projects were funded by UK research councils and the UK government, among others. In 2011, the Centre became entirely independent of the University¹⁴⁴ and was renamed the Centre for Substance Use Research (CSUR) in November 2015.¹⁴⁵ In 2016, the University confirmed it was not in any way affiliated with the CSUR and McKeganey no longer held any position there, honorary or otherwise.¹⁴⁶ On its website the CSUR describes itself as “a specialist agency undertaking research within the substance use field within the U.K., E.U., and the U.S.”.¹⁴⁷

CSUR has previously received funding from tobacco companies including PMI, BAT, and Fontem Ventures, a subsidiary of Imperial Brands.¹⁴⁸ In 2014 McKeganey helped BAT oppose the introduction of Plain Packaging in the UK. McKeganey prepared a 82 page report for BAT which was included in BAT’s submission to the UK’s second public consultation on plain packaging in 2014.¹⁴⁹¹⁵⁰ In the report, McKeganey supports BAT’s view that there is no evidence to suggest that plain packaging will reduce smoking prevalence, and that packaging is not “a factor that influences people’s decisions to start, stop, or re-start smoking”.¹⁴⁹¹⁵⁰

In May 2016, dismissing the legal challenges to the UK’s plain packaging legislation brought by the big four tobacco companies, the High Court of Justice’s ruling criticised McKeganey’s findings and the methodology they were based on:¹⁵⁰

“What I find unacceptable is the preparation of a report which by its total refusal to engage with any of this contramaterial simply conveys the impression that it does not exist and that the best way to refute it is to ignore it. Yet, at the same time and inconsistently, Professor McKeganey accepts that the principles of transparency and openness are “foundational tablets of the scientific enterprise”. Had Professor McKeganey confronted head-on the contrary evidence, including that from the tobacco companies, then it is hard to see how he could have advanced the opinions that he did; at the very least he would have been compelled to provide a proper rationale for why his opinion could be sustained in the light of this inconsistent evidence.”

More recently, McKeganey and CSUR have been working for e-cigarette company JUUL Labs, in which tobacco giant Altria has held a majority share since December 2018. In March 2019 JUUL Labs promoted a study by CSUR (funded by JUUL) which found that the JUUL e-cigarettes “dramatically” cut adult smokers’ cigarettes consumption.¹⁵¹¹⁵²

Malawi: Centre for Agricultural Transformation

In July 2018 the Foundation launched a request for proposals up to the grant amount of US $10 million to establish a Centre for Agricultural Transformation (CAT) in Malawi.¹⁵³ According to expression of interest documents, the CAT aims to support smallholder Malawian farmers in diversifying their incomes and livelihoods to reduce their reliance on tobacco farming. The Centre stated that it would achieve this through the development and implementation of new technologies, partnerships and income opportunities.¹⁵⁴ In an operations statement released in May 2020, the Foundation outlines the CAT’s delivered and planned activities which aim to “Promote and accelerate the use of digital technologies and advanced data analytics to accelerate agricultural transformation in Malawi”.¹⁵⁵ As of May 2020 it is still to appoint a director.

For more information see Centre for Agricultural Transformation.

Other Centres Funded by FSFW

South Africa: African Centre of Excellence for Smoking and Mental Health

In May 2018 the Foundation awarded the University of Cape Town’s (UCT) Department of Psychiatry & Mental Health US$70,800 to set up an African Centre of Excellence for Smoking and Mental Health.⁹² The Principal Investigator on the grant was named as clinical psychologist Dr Adele Pretorius.¹⁵⁶ In May 2019, the FSFW recorded that it had paid out US$24,517 to UCT.⁹² In October 2019, UCT’s Research Office confirmed that the grant had come to an end and that a policy was being put in place to disallow further funding from the tobacco industry.¹⁵⁷

United States: Behavioral Psychology Centre of Excellence

In December 2018, the Foundation awarded the Florida-based Fox Foundation US$59,910 to scope out the possibility of a Behavioral Psychology Centre of Excellence.⁹² The Fox Foundation describes itself as a “non-profit corporation whose mission is to identify, develop and implement economically sustainable solutions for smoking cessation and other problems that can be addressed through behavior modification.”¹⁵⁸ The Fox Foundation did not receive further FSFW funding in 2019.⁹⁴

According to documents filed in February 2019 in the State of Florida,¹⁵⁹ the Foundation’s chairman is Vaughn Volpi and its directors are Geoff Comrie and Charles Roe.

Vaughn Volpi is President for Tampa-based security company Pica.¹⁶⁰ The “principle office address” for the Fox Foundation, as of 9 February 2019, is W. Gandy Blvd, which matches the address of Pica’s Tampa office.¹⁵⁸¹⁶¹

Volpi’s biography at Pica’s website states that his areas of expertise include “intellectual property investigations and program management, global network and intelligence management, Internet fraud and security and undercover investigations”.¹⁶⁰ He was previously the Co-Chairman of an anti-counterfeiting organisation, the International Anticounterfeiting Coalition (IACC) Investigators Committee.¹⁶⁰ In June 2019, the IACC website stated that amongst its members were PMI, Japan Tobacco International (JTI), and JUUL Labs.¹⁶² Pica was not listed as a member.

India: Center of Excellence

In May 2018 the Foundation awarded Metaform Ventures LLC US$100,000 to develop a proposal to establish a Center of Excellence in India.⁹² Metaform is a venture capital company registered in Pleasanton, California and documents filed with the State¹⁶³ show it was registered in September 2017 and the Chief Executive is Jain Nilesh. It invests in technology companies and has increasingly looked at start ups in India.¹⁶⁴

It is unclear what the focus of this Research Centre will be. In November 2018, Nilesh said in an interview with NewsBarons that:

“Healthcare in India is plagued for multiple reasons like poor infrastructure, lack of medical professionals in the semi urban and rural locations and the cost of medical treatment. Technology can play a major role in providing real time quality healthcare solutions across locations to a majority of our population who do not have access to basic healthcare facilities”.¹⁶⁵

The FSFW 2019 tax return reported US$446,411 paid to Metaform in 2019, with US$1,041,625 committed in future funding.⁹⁴

India: Center of Excellence on Harm Reduction Science

In May 2018, the Foundation awarded US$67,600 to the P.N. Srivastava Foundation For Scientific Education & Research in Shillong, for a “Detailed Project Development for Establishment of a Center of Excellence on Harm Reduction Science.”⁹² It is unclear whether the funding is connected with Metaform’s project in India or is a separate venture. In May 2019, only US$33,800 had been paid out, with no funding awarded in 2019.⁹²⁹⁴

The Foundation appears to have only been registered the same month it was awarded the grant and has no apparent other income.¹⁶⁶ The website given as its address on documents filed with the local government does not work. The address appears to be the Department of Biochemistry at North-Eastern Hill University (NEHU) in Shillong. The three trustees are Rajeshwar Nath Sharan, Rajendra Prasad and Prabodh Jhingan. The Trustees appear to be all affiliated with NEHU. Jhingan retired from the university in 2011 after 35 years in its Cultural & Creative Studies Department.¹⁶⁷ Sharan is Professor at Department of Biochemistry and Director of Design Innovation Center at the university.¹⁶⁸

On 31 May 2019, a paper allegedly written by Rajeshwar Sharan, Konstantinos Farsalinos, and Christopher Russell (Deputy Director of CSUR) and named ‘The Prospects of e-cigarettes in India: Overview of Evidence, Opportunities and Challenges Based on Experiences in Western Countries’ was press released by an Indian media outlet.¹⁶⁹¹⁷⁰ The key message relayed was that “it is imperative that India learns from the experience of other countries, and provide tobacco users with a less harmful alternative, rather than prohibiting e-cigarettes and missing out on an unprecedented opportunity to help adult smokers in India”.¹⁷⁰ That same day, the Indian Council of Medical Research (ICMR), the government’s research arm, launched its White Paper on e-cigarettes which concluded that the products “have a net negative impact on public health”, and recommended a “complete prohibition on ENDS or e-cigarettes in India in the greater interest of protecting public health” and that the products .¹⁷¹

TobaccoTactics Resources

• Foundation for a Smoke-Free World
• Foundation for a Smoke-Free World People
• Foundation for a Smoke-Free World: Research Database
• COREISS
• CoEHAR
• Centre for Agricultural Transformation

References

The post Foundation for a Smoke-Free World Centres of Excellence appeared first on TobaccoTactics.

Background

Polosa is the Director of the Institute of Internal and Emergency Medicine and the School of Specialization in Rheumatology of the University of Catania in Italy. In March 2018 he founded the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), an interdepartmental Research Centre within the University of Catania.¹⁷³¹⁷⁴ This has received significant funding from a tobacco-industry front group, the Foundation for a Smoke-Free World (see below for more).

Polosa works in the field of clinical bronchoprovocation (airway-challenge studies) and has authored more than 300 peer reviewed articles mainly covering respiratory medicine, clinical immunology, and tobacco addiction.¹⁷⁵ In 2014 a fellow researcher dubbed Polosa the “most prolific” academic author in the field of e-cigarettes.

After many years as President of the Italian Anti-Smoking League, LIAF (Lega Italiana Anti Fumo), Polosa now serves as LIAF’s Chief Scientific Advisor.¹⁷⁶ He is also a Special Scientific Advisor to the International Network of Nicotine Consumer Organizations (INNCO).¹⁷⁷ The INNCO was formed in 2016 and represents organisations promoting newer nicotine and tobacco products such as e-cigarettes (also known as electronic nicotine delivery systems, or ENDS), heated tobacco products and snus. It describes itself as “the collective voice for the most influential nicotine consumer organisations in twenty seven nicotine consumer organisations in twenty five countries across five continents who each recognise that there are safer ways to enjoy nicotine consumption than tobacco smoking”.¹⁷⁸ In November 2018 INNCO was granted $100,300 from the Foundation for a Smoke-Free World to strengthen “nicotine consumer organizations”.

Moreover, since 2019 Polosa has served on the Medical and Scientific Advisory Board (MSAB) of PharmaCielo, a Canadian company which manufactures and sells medicinal grade cannabis oil.¹⁷⁹ The MSAB is led by Delon Human.

According to a statement from Polosa written in 2020, he serves pro bono as the Chair of the European Technical Committee for standardization on Requirements and test methods for emissions of electronic cigarettes (CEN/TC 437; WG4).¹⁸⁰

In December 2023 The Times newspaper published an article that described how Riccardo Polosa’s research was used to help promote e-cigarettes in the UK.¹⁸¹

Direct and Indirect Relationships with the Tobacco Industry

Research Funded by Juul Labs, Inc. (2020)

In October, 2020 Polosa was listed as the scientific director on a paper disseminated on the pre-print platform medrxiv. The paper (a pre-print i.e. an unpublished, non-peer-reviewed research article) detailed the research protocol for a multicentre trial – the GENESIS trial – investigating the effects of switching to different e-cigarettes in smokers with schizophrenia spectrum disorders.¹⁸² The research declared it was ‘supported by an Investigator-Initiated Study award by JUUL Labs Inc. (Juul Science Programme)’.

The trial was registered on the clinicaltrials.gov website in June 2020 and is estimated to run until June 2022.¹⁸³

CoEHAR Funded by Foundation for a Smoke-Free World (2018-2021)

Between 2018 and 2019, Polosa’s CoEHAR was given grants totalling $8,242,298 from the Foundation for a Smoke-Free World (FSFW), an ostensibly independent scientific organisation aimed at ‘accelerating the end of smoking’ which is solely funded by Philip Morris International (PMI). According to FSFW’s 2019 tax return, it has also approved another $22,928,186 in grant funds for CoEHAR.¹⁸⁴

FSFW plans to fund CoEHAR until at least March 2024, according to its website.¹⁸⁵

Consulted for British American Tobacco (2018)

After giving oral evidence at the UK Parliamentary Science and Technology Committee hearing into e-cigarettes on 9 January 2018, Polosa wrote a letter to the Committee dated February 2018.¹⁸⁶ In this letter Polosa confirmed that he was working for Swiss-based consultancy firm Health Diplomats, a company founded by Delon Human and which he described as providing “…harm minimisation solutions to the alcohol, food & beverage, pharmaceutical, tobacco and nicotine industries”.¹⁸⁷ In particular, Polosa said he was the “Medical Contact” in “3 BAT-funded clinical trials in respect of its e-cigarette and tobacco heating devices and their potential for harm reduction”. He described his role as helping “with the design of the clinical research protocol, to provide guidance on any medial and safety issues related to study participants, and to oversee with the analysis and interpretation of clinical trial data and the reporting of clinical trial results”.

While Polosa has declared this previous funding from Health Diplomats in conflict of interest statements of research papers, he often does not declare that this work involved the above research assistance to BAT.^188189190

Harm Reduction Research Funded by Philip Morris International (2017/18)

In 2017 Polosa was awarded €968,708.00 from Philip Morris Products SA, a subsidiary of Philip Morris International (PMI) for “A 12-weeks open label, non-inferiority trial comparing HnB not Burn products vs ECs e-cigarettes in terms of efficacy and adoption rates, acceptability, tolerability, and tobacco harm reduction in healthy smokers, not motivated to quit”.¹⁹¹¹⁹²

The trial was originally scheduled to commence on 20 December 2017, but records from the U.S. National Library of Medicine, which houses a clinical trials registry, show that its actual estimated start date was 18 July 2018 with an expected completion date of 18 July 2019.¹⁹³ Records show that the actual study start date was 25 May 2019 and the actual completion date was 25 May 2020.¹⁹⁴ In March 2018 PMI consented to a request to change the study’s Principal Investigator from Polosa to Dr Enrico Mondati, Polosa’s departmental colleague at the University of Catania and fellow member of CoEHAR’s Founders Council.¹⁹⁵

In January 2020, Polosa was listed as author on a research paper which outlined the study protocol for the above clinical trial.  The authors declare the research was ‘supported by an Investigator-Initiated Study award by Philip Morris Products SA’. The paper states Polosa was one of the authors ‘responsible for designing the study protocol’.¹⁹⁶

Collaborated with Tobacco Industry Scientists (2017/18)

In September 2017, Polosa took part in a symposium titled “Approaches for the assessment of next generation products” at the 53rd Congress of the European Societies of Toxicology (‘EuroTox 2017’) held in Slovakia.¹⁹⁷

Polosa presented on “Tobacco harm reduction and e-cigarettes” and fellow symposium presenters included tobacco industry representatives Manuel Peitsch (PMI’s Chief Science Officer), Chris Proctor (BAT’s Chief Science Officer), and Thord Hassler (Vice President Research and Development Swedish Match). In a paper published in May 2018, first author Peitsch and co-authors Polosa and others summarised the symposium presentations and further promoted the use of newer products in a tobacco harm reduction approach to health regulation.¹⁹⁸ The article explicitly states that “Riccardo Polosa’s research in harm reduction has not been supported by the tobacco industry”. Yet, as we have seen above, only months prior to publication, Polosa was awarded close to €1 million by PMI for a 12 week trial to assess heated tobacco products and e-cigarettes.

Research Funded by Philip Morris USA (2003-2005)

In April 2004, a LIAF press release announced that its President, Polosa, and Philip Morris USA (PM) were to jointly develop a research project on nicotine addiction. Internal tobacco industry documents show that Polosa applied to PM’s External Research Program in August 2002, requesting US$ 281,080 for a research study titled “Cigarette smoke and endothelial/platelet activation: Evaluation of prothrombotic markers during smoke cessation”.¹⁹⁹ The budget was to cover 20% of Polosa’s time as the study’s Principal Investigator, amounting to US$ 19,900 over two years, and would further fund one research technician post and co-fund a fellowship (see Image 1).

The PM grant ran from 1 May 2003 to 30 April 2005,²⁰⁰ and a signed agreement between PM and the University of Catania confirms Polosa’s key role in the project, deeming his services as “essential to the research being performed”.²⁰¹

Another internal PM document suggests the company eventually awarded Polosa and his team a total of US$ 316,060; US$ 189,575 in the first year, and US$ 125,485 in the second.²⁰² Under the terms of the agreement, Polosa and colleagues were required to acknowledge PM funding in all papers published resulting from this work.

Invited Speaker at Events

In 2015, 2017 and 2018 Polosa was an invited speaker at the Global Tobacco and Nicotine Forum, an annual tobacco industry event previously known as the Global Tobacco Networking Forum.^203204205 See also the following pages:

• Global Tobacco and Nicotine Forum 2018
• Global Tobacco and Nicotine Forum 2017
• Global Tobacco and Nicotine Forum 2015

In 2020 and 2019, Polosa was an invited speaker at the Global Forum on Nicotine, an event which has provided a platform for the tobacco industry and others to promote tobacco harm reduction.²⁰⁶²⁰⁷

Conflict of Interests: Lack of Transparency

Polosa’s conflict of interest statements have been inconsistent, and in general he has been more transparent about his links with the e-cigarette and pharmaceutical industries, than about his links with the tobacco industry.

In a letter to the UK parliament in February 2018, while disclosing his links to the e-cigarette company Arbi Group Srl, the UK Electronic Cigarette Industry Trade Association (ECITA), and “BAT subsidiaries” as well as the 2003 funding from Philip Morris US, Polosa did not mention that he was, at the time, principal investigator of a large PMI-funded study.
In 2015, Polosa lobbied the Australian government on the topic of tobacco harm reduction without disclosing any conflicts of interest.²⁰⁸

In peer-reviewed publications on tobacco harm reduction, Polosa has frequently disclosed research funding from a range of pharmaceutical companies such as GlaxoSmithKline, Pfizer and Boehringer-Ingelheim, as well as financial contributions from e-liquid manufacturers. However, while his Philip Morris funding is acknowledged in the publications which originated directly from Philip Morris-funded research,²⁰⁹²¹⁰ Polosa’s subsequent publications on the topic of tobacco harm reduction fail to declare this.^{211212213214215216217218219220}

Further, in publications where Polosa does list CoEHAR as an affiliation, often no mention is made of CoEHAR’s links to FSFW, nor FSFW’s links to PMI in conflicts of interest statements.^221222223224

In his role as a speaker at the 2015, 2016, and 2017 E-cigarette Summit, Polosa declared funding from pharmaceutical companies GlaxoSmithKline and Pfizer, and that he served as a consultant for Pfizer and Arbi Group Srl , the distributor of Categoria e-cigarettes. He did not declare his funding from Philip Morris.²²⁵²²⁶

Tobacco Tactics Links

• CoEHAR
• Philip Morris International
• Foundation for a Smoke-Free World
• Foundation for a Smoke-Free World Grantees
• Foundation for a Smoke-Free World Centres of Excellence
• E-Cigarettes: Mixing Research and Marketing
• Global Tobacco and Nicotine Forum
• Polosa has also been a speaker at the Global Forum on Nicotine

References

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