Heated Tobacco Products

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To secure the tobacco industry’s medium to long-term future, in light of growing tobacco regulations and a rapidly shrinking cigarette market, particularly in Western Europe, the US and other high-income countries,  tobacco companies have been developing and marketing so-called ‘Next Generation Products’ (NGPs), which include snus, e-cigarettes, and Heated Tobacco Products (HTPs).12 They are also increasingly marketing these products in low and middle income countries.3

This overview page focuses on HTPs. It explains what these products are, summarises tobacco company investments in this product segment, and discusses the main public health debates around these products. It does not include all research updates on the potential health benefits/risks of HTPs but does refer to some key and emerging independent analyses. It primarily looks at how the tobacco industry uses its own scientific studies, and the concept of harm reduction, to further its business goals. We discuss whether HTPs, e-cigarettes and other kinds of ‘smokeless’ tobacco can help advance public health on our page on Next Generation Products (NGPs).

Background

Unlike e-cigarettes, HTPs contain tobacco.4 The World Health Organization (WHO) describes the tobacco in these products as being “heated without reaching ignition to produce an emission containing nicotine and other chemicals”.5 According to tobacco companies, by heating the tobacco, rather than burning like conventional cigarettes, the formation of harmful substances created at high temperature associated with combustion is significantly reduced.6 This tobacco industry reduced-risk claim has yet to be fully supported by independent scientific evidence, as discussed below. IQOS, produced by Philip Morris International (PMI) is the most widely available HTP, with by far the biggest share of the heated tobacco market, but the other big three transnational tobacco companies (TTCs) all now have HTPs, Imperial Tobacco being the last to launch a product in 2019 (see below). South Korean tobacco company KT&G also has a growing share of the HTP market and, in 2020, a new partnership with PMI to commercialise KT&G’s range of Lil HTPs and e-cigarettes.78 China National Tobacco also has an HTP called Mok.910 This page focuses on the four main transnational tobacco companies and their interests in HTPs.

In 2017, the British Government classified HTPs into three categories:11

  1. Processed tobacco heated directly to produce vapour;
  2. Processed tobacco designed to be heated in a vaporiser;
  3. Devices that produce vapour from non-tobacco sources, where the vapour is then passed over processed tobacco to flavour the vapour.[referred to here as HTP ‘hybrids’]

In its 2020 briefing the WHO identified the same three types, with the addition of new carbon tipped devices.5

The image gallery below shows examples of tobacco companies’ HTPs. The images are screenshots from the manufacturers’ websites taken in June 2017, with the exception of Imperial’s Pulze (2019).12

Image 1. JTI’s ZeroStyle

Image 2. PMI’s IQOS

Image 3. BAT’s iFuse

Image 4. JTI’s PloomTech

Image 5. BAT’s glo

Image 6: Imperial’s Pulze

Despite significant media attention on the tobacco industry’s HTP pursuits,131415 and the technology being initially marketed as “a real game changer”,16 in 2019 HTPs still represented less than 2% of the retail value of the global tobacco market, according to market research company Euromonitor International.17 However, combustible tobacco (mainly cigarettes) continued to dominate the market with a 94% share, only slightly down from 95% in 2018. 17

Heated Tobacco Product Technology Pioneered in 1980s

Image 7: Accord Advertisement by Starcom Media Services18

HTP technology is not new. It was first developed by tobacco companies in the 1980s to address concerns about second-hand smoke exposure. In 1988, the American tobacco company RJ Reynolds (RJR) launched the first HTP, Premier, in several American cities.1920 The company’s objective behind developing Premier was to “produce a cigarette which provided the enjoyment and satisfaction of other cigarettes, but without many of the perceived negatives”.19 Richard Kampe, then President RJR Development, said: “What it all comes down to is a cleaner smoke for smokers and those around them”.21 Premier was withdrawn from the market in early 1989 reportedly because smokers “did not like Premier’s taste or smell”.22

In 1996, RJR started test marketing its second HTP, called Eclipse, marketed to smokers under the slogan “imagine the unimaginable”.23 The company purported that Eclipse was a new cigarette “with nearly 90 percent less second-hand smoke”.24 This claim was refuted in 2002 by an independent study which found that Eclipse was at least as toxic as conventional cigarettes.25 The product was on the American market until 2014.26

In 1998, Philip Morris launched its first HTP, called Accord, under the slogan “the time is right” (Image 7).27 The company commissioned Starcom Media Service to run a media campaign to create awareness of the product and communicate its perceived benefits, including reduced second-hand smoke, smoke odour and ash.1828 Accord remained on the market until 2006, when it was discontinued due to poor sales.29 Consumers allegedly complained that the product was not as satisfying as conventional cigarettes.29 In 2007, PMI briefly rebranded Accord to Heatbar and trialled the product on the Swiss and Australian markets. It’s unclear when the product was withdrawn from these markets.30

It appears as though none of the early HTPs gained commercial success, and none were marketed as potentially less harmful. A 2016 study by Dutra et al.31 concluded that the tobacco industry’s early HTP pursuits were primarily driven by non-health related reasons: to evade smoke-free regulations and to complement, rather than compete with, conventional cigarettes.

A New Take on an Old Idea

2014 marked the start of a phase of new HTP launches by tobacco companies. RJR (by then owned by British American Tobacco) launched Revo (allegedly a revamped version of Eclipse) under the banner “an unconventional cigarette”,32 PMI introduced IQOS (allegedly a revamped version of Accord)33 under the banner “this changes everything”,34 and BAT launched iFuse in 2015.35

By early 2018, all transnational tobacco companies except Imperial Tobacco had included HTPs in their product portfolio. PMI promoted them as part of its purported goal of a “smoke-free future” and BAT framed them as part of its “Transforming Tobacco” programme.363738 In 2019, Imperial Tobacco (now Imperial Brands) also launched an HTP.39

By 2019, BAT and PMI were testing devices using a carbon tip as the heat source (see below). In 2020, the two companies had active legal claims against each other, in relation to patents for the tobacco heating technology in IQOS and glo.40

Japan Tobacco International

In 2010, JTI acquired a 27% share in San Francisco-based entrepreneurial company Ploom Inc., signing an agreement to commercialise Ploom Inc.’s HTP outside the US.41 In February 2015, JTI and Ploom (later trading under the name ‘Pax Labs’) ended their partnership and JTI acquired the intellectual property rights for Ploom HTPs.42 One year later, JTI launched an upgraded version, called PloomTech, with new products planned.43 These HTPs heat small pods of tobacco, through a capsule of e-liquid, and so are HTP ‘hybrids’.  The pods are sold under the Winston and Mevius brands.4445 In the US, PloomTech is marketed as Logic Vapeleaf.46

In February 2018, the company announced that it would launch another HTP by the end of the year.47 By 2019, the company had three Ploom products in its portfolio.

Philip Morris International

PMI first launched IQOS (reported at the time as standing for I Quit Ordinary Smoking)48 in the second half of 2014 in Italy, and later trialled the product in Japan.49 The electronic device heats tobacco sticks, called HEETS. According to PMI, in February 2018 IQOS was available in around 30 countries.50 The United States was added to the list in 2019, and by July 2020 PMI’s website stated that IQOS was on sale in over 50 markets.51 Altria has an agreement with PMI to distribute and market its HTPs and e-cigarettes  in the US and launched the product there in 2019, initially in Atlanta, Georgia.52 In July 2020, it was reported that Altria was also selling IQOS in Richmond (Virginia) and Charlotte (North Carolina), with plans to roll out to four more US cities in the following 18 months.53

PMI applied to have IQOS classified as a Modified Risk Tobacco Product (MRTP) by the US Food and Drug Administration (FDA) in December 2016.5455 This was prior to its application for Pre-Market approval (PMTA), submitted in March 2017.56 The US Tobacco Products Advisory Committee (TPSAC) recommended against approving PMI’s application to market IQOS as a reduced risk product.57 However, on 7 July 2020, partial approval was given and IQOS was granted “modified exposure” status.5859 See below for details of the FDA’s decision, the implications and PMI’s reaction.

PMI has been testing a carbon tip device, called TEEPS, which it alleges is much closer to the look and feel of a conventional cigarette than IQOS.6061 This is likely to be similar to BAT’s Neocore device (see below). It conducted a “small scale city test” in the Dominican Republic in December 2017, and intended to “consumer test” the product in late 2020.6263 As of August 2020, TEEPS did not yet appear to be on the market.61

Both companies state that these products resemble traditional cigarettes.606164

British American Tobacco

BAT initially focused its NGP investment on e-cigarettes (for more detail see the page on E-cigarettes: British American Tobacco). In 2015, BAT entered the HTP market with the launch of iFuse, a product that heats an e-liquid, which creates a vapour which is passed through a tobacco pod (similar to JTI’s PloomTech).65 In 2016, BAT launched Glo, which the company has claimed to be “a real game changer for consumers”.16 Glo, like IQOS, uses a battery operated device to heat tobacco sticks (called Neostiks and sold under BAT’s cigarette brand Kent).66 According to BAT, glo is a simpler and more practical alternative to IQOS.67 In 2017, the product was sold in five countries, but BAT said that it aimed to launch glo in a further 16 markets in 2018.68 By 2019, glo was sold mainly in the large markets of Japan and South Korea, and the product was being rolled out in other countries, including in Eastern Europe, Russia and Canada.6970 However, glo was discontinued in Canada in 2019, in favour of BAT’s e-cigarette Vype.71 By July 2020, the glo website linked to retail sites in 17 countries, other than Canada, including the new markets of Malaysia, Hong Kong and Germany.72 The latest brand variation was glo Hyper.73

The company was also developing a carbon tip device, under the name NeoCore.64 This appeared to be a version of an earlier Reynolds product Revo, renamed Eclipse (BAT acquired Reynolds in 2017).64 Although Neocore was cleared for sale by the FDA, and BAT were reported to be testing the product with consumers in 2018,74 it did not appear on the market and by July 2020 was no longer on BAT’s website.647375

Imperial Tobacco

At the end of 2017, Imperial Tobacco was the only transnational tobacco company not selling HTPs. The company’s NGP strategy had largely focused on e-cigarettes, and it had publicly dismissed HTP health claims made by its competitors, asserting “there’s no difference really between those products and traditional tobacco products” and “It’s probably better described generically as ‘heat and burn’ rather than ‘heat not burn’”.76 In 2015, Imperial Tobacco scientists published a study in the Environmental Analytical Chemistry journal that concluded that PMI’s IQOS released tobacco-containing side stream emissions, and as such, the scientists recommended that HTPs should be covered by smoke-free legislation.77

However in early 2018, apparently under pressure from shareholders, Imperial announced that it was after all developing and trialling HTPs.78798081 In May 2019, Imperial’s HTP Pulze was launched in Fukuako, Japan.8283 The company said it was “evaluating other potential market launches for the brand”.1284

Global HTP Market

Since 2014, the HTP market has grown rapidly. In 2014, 100,000 devices and 15.3 million heated tobacco (HT) sticks were sold worldwide; in 2019, this had increased to 12.8 million devices and around 69.5 billion sticks (Figure 1).17

Figure 1: Relative retail value of tobacco products. NB graph shows values above US$600,000 million, see pie chart below for a proportionate view. (Source: Euromonitor International)

In the same period, the global retail value of HTPs increased exponentially, from US$15.6 million in 2014 to around US$15.2 billion in 2019, an increase close to 10,000%.17. It is noteworthy that the composition of the retail value changed: in 2014 HT sticks accounted for around one third of the total retail value, and devices for the remaining two thirds. By 2019, HT sticks made up almost 95% and devices just over 5% of the retail value.17 This is likely due to the high initial take up and purchase of devices.

The key regional markets for HTPs are South East Asia (mainly Japan and South Korea) followed by Western Europe and Eastern Europe. In 2019, Japan remained by far the biggest single market for HTPs (nearly US$8.6 billion by retail value) followed by South Korea (US$1.6 billion), and Italy (over US$1 billion). Russia also had sales of HTPs worth over US$1 billion in 2019, an increase of 200% since 2018. Other large and fast growing markets, in terms of retail value, were Romania (US$400 million, up 53%), Germany (US$342 million, up 91%), Poland (US$233 million, up 160%), the Czech Republic (US $250 million, up 72%) and Ukraine (US$230 million, up 220%). The value of the new HTP market in Malaysia increased by 1,200%, from US$3.2 million in 2018 to over US$40 million the following year. Latvia also saw in increase of 655%, and retail value more than doubled in Lithuania and Khazakstan, although all were small markets.17

PMI quickly established dominance of the growing HTP market with IQOS, but slightly different pictures emerge when looking at the figures for devices and sticks. Devices are not considered to be tobacco products, as they are bought separately and less frequently, so the market share for HT sticks should be considered comparable to the cigarette market.

Although JTI held a similar share of the device market to PMI  in 2014 (42% to PMI’s 48%), according to Euromonitor, by 2015 PMI’s share had increased to over 80%, while JTI’s fell to less than 8%.(Figure 2)17 Prior to the acquisition of Ploom by JTI, Pax Labs also lost market share to IQOS. Over the next 3 years, first JTI and then BAT started to challenge this dominance (with Ploom and glo respectively), pushing PMI’s share back to around 50% of the device market in 2018.17 In 2019, the picture changed again, with PMI’s share once again on the increase, and JTI’s and BAT’s shares being squeezed. This trend is likely to continue, or accelerate, after the launch of IQOS in the US. Between 2017 and 2019, KT&G’s share also increased from around 1% to 7.5%, prior to its distribution deal with PMI.17

Figure 2: Heated Tobacco Devices: Change in HTP device market share 2014-2019 (%)(Source: Euromonitor International)

Similarly to the device market, JTI appeared to lose most of its share of the heated tobacco stick market to PMI between 2014 and 2015 (Figure 3). Although JTI began to make some gains in 2016, BAT overtook JTI and by 2019 held a 12% share to JTI’s 5%.  PMI held its share of over 90% until 2017, only falling below 80% in 2018 and 2019.17

Figure 3: Heated Tobacco Sticks: Change in tobacco stick market share 2014-2019 (%) (Source: Euromonitor International)

The WHO stated in 2020, that HTPs are available in markets where they are currently banned.85 See below for more on the regulation of HTPs.

HTP Adoption Rates

Japan and South Korea

BAT, PMI and JTI have used Japan, and to a lesser degree South Korea, as trial markets for their HTPs. Both tobacco markets are dominated by companies which were former state monopolies, Japan Tobacco and Korea Tomorrow & Global Corporation (KT&G), with PMI in second place in both cases.  Both had very high smoking rates and a preference for low tar brands, which may make it easier for smokers to switch to alternatives.86

Preliminary sales reports by the tobacco companies and industry analysts showed strong adoption rates of HTPs. According to PMI, by March 2017 the tobacco company had sold three million IQOS devices in Japan, saying that “demand continues to outstrip supply”.87

Independent academic analysis of data from the 2018 International Tobacco Control (ITC) Japan Survey, a nationally representative web survey,  found that the overall prevalence of HTP use was 2.7% , equivalent to nearly 4.4 million people if applied to the whole population of Japan.88 The researchers found that over 60% of HTP users reported using IQOS devices (representing approximately 2.6 million people).88 IQOS was preferred by younger people and daily users, while JTI’s Ploom TECH was more popular among older people and less regular users.88. In contrast to PMI’s claims, the researchers found that most users of HTPs also smoked combustible cigarettes.88

BAT funded market research in Japan in 2018, conducted by Kantar, which concluded that the prevalence of HTP use was much higher at around 5%.89 However, the sample was drawn from three urban areas, and therefore was not representative of the whole population. This study did not identify brand preferences.

It has been suggested that HTPs success in Japan might be connected to restrictive e-cigarette legislation.9088 E-cigarettes containing nicotine liquid are covered by pharmaceutical regulation, and as of 2020 have not been approved for sale in Japan.91

In 2017, Roberta Palazzetti, President of BAT Japan, described the country as “the first battleground for heated tobacco products”, explaining that BAT had chosen Japan because “Japan’s consumers are highly receptive to innovation”.68 Others have suggested that the Japanese success of HTPs may also be linked to the Japanese values of cleanliness, discretion and social politeness, which do not necessarily apply to other markets.9293

Researchers have raised concerns that as IQOS was marketed in Japan as a high tech, aspirational product it might appeal more to youth and young adults.8893 A study based on 2017 data found that HTPs were being used by Japanese adolescents, although still at lower rates than combustibles and e-cigarettes.94

Philip Morris used a similar marketing approach when it launched IQOS in South Korea in June 2017.95 Research conducted three months later found that “Awareness, experience and use of IQOS among young Korean adults were relatively higher than among their Japanese counterparts”.96 Subsequent studies found high poly use of products (HTPs, e-cigarettes and conventional cigarettes) among young people in  South Korea.9798

Research in the US, including one study using PMI’s submission to the FDA, found that HTPs were likely to appeal to adolescents and young adults.99100

Take up supported by favourable taxation?

In Europe, Italy was at the forefront of HTP developments. PMI chose Milan to trial IOQS reportedly due to beneficial tax treatment of the product by the Italian government (50% lower than conventional cigarettes, and at the same level as e-cigarettes) as well as more lenient packaging and marketing regulations.101102103 Research from Italy indicated that PMI’s annual sales of IQOS grew from 11 tonnes in 2015, to 83 tonnes in 2016, and 519 tonnes in 2017.102 In contrast, in July 2017, BAT Chief Executive Nicandro Durante reported that BAT had seen “no success whatsoever” with glo in European markets like Italy and Switzerland.32 By 2019, BAT appeared to have had a little more success Italy, having gained around 15% of the market by value, but PMI continued to dominate.17

The FCTC requires that HTPs are taxed as tobacco products, but they are taxed more favourably than cigarettes in a number of countries (see The Campaign for Tobacco Free Kid’s web pages on global tobacco taxation). It is not clear if this always results in lower prices for the consumer, and how this relates to consumption and adoption rates. A research study in 2018 concluded that: “The tax advantages being given to HTPs may instead of providing a price signal to a consumer looking to switch, be providing a profit signal to tobacco companies to switch over to selling more HTPs and fewer combusted cigarettes”.104

In 2020, the European Commission announced a review of tax rates for HTPs and e-cigarettes, with a view to achieving harmonisation of product definitions and taxation. The consultation phase was announced on 2 June, and intense lobbying for the tobacco industry was anticipated.105106107 The US based Tax Foundation, a think tank with tobacco industry links, published an article the next day detailing existing tax rates in Europe and outlining proposals for change.108

Harm Reduction: A Tobacco Solution to a Tobacco Problem?

Tobacco companies frame HTPs as products which should be considered safer than cigarettes, while the WHO continues to urge caution, stating that independent scientific evidence does not bear out these claims.

The general independent scientific consensus is that when smokers switch fully from conventional cigarettes to HTPs, they are exposed to reduced levels of some harmful substances. However, HTP users are also exposed to higher levels of other potentially harmful substances and the subsequent risks of harm, especially after long-term use, remain unknown. While the industry promotes evidence to support its own claims of reduced harm, independent research appears to show that, although HTPs reduce exposure, they cannot be said to be less harmful than cigarettes because the exposure levels are still high enough to cause harm.  In July 2020, the Tobacco Control Research Group (TCRG) produced a STOP briefing, summarising the evidence from academic research on IQOS, including independent analyses of PMI’s own data submitted to the FDA which suggest the HTP may be as harmful as smoking.109

The Industry Narrative

RJ Reynolds’s executive Steven Alderman testified in an American court in 2016 that there is no such thing as a ‘safe’ tobacco product.110 Yet, some tobacco manufacturers have marketed HTPs with direct and indirect claims that they are less toxic or less harmful than conventional cigarettes.111112113

BAT and PMI have set up dedicated websites (bat-science.com, pmiscience.com) to showcase their harm reduction efforts, and have published their findings in scientific journals.11411589116117

In December 2016, PMI submitted a ‘modified risk tobacco product’ (MRTP) IQOS application to the US Food and Drug Administration (FDA), which if successful, would allow PMI to market IQOS in the US as with specific reduced risk claims.118 Although BAT indicated that it would undertake similar regulatory steps with glo, as of July 2020 BAT had not submitted an application to the FDA.32

In January 2018, the Tobacco Products Advisory Committee (TPSAC) to the FDA, following careful scrutiny of PMI’s scientific data, recommended against approving PMI’s application to market IQOS as ‘reduced risk’. The Committee concluded that the data had shown that IQOS users were exposed to lower levels of harmful chemicals, but had not demonstrated that this would translate into a measurable reduction in death and disease.119

However, on 7 July 2020, the FDA partially approved PMI’s application. While it concluded that the data PMI submitted showed that IQOS may reduce exposure to harmful substances, it did not agree that IQOS reduces the risk of disease and death, compared to smoking cigarettes, and so had failed to meet the higher standard of “risk modification”.109 Nevertheless, immediately after the FDA’s decision, PMI launched an international PR campaign, calling it a “public health milestone” (see below).109120 PMI stated that they intended to pursue full approval, and that the FDA had “left the door open to continue the dialog with them on precisely the next level”.121

Emerging Independent Evidence

Public health advocates have cautioned that the short and long-term health effects on the consumer of HTPs remain unclear, and that due to the tobacco industry’s long history of deceit over the health risks of smoking,122 there is an urgent need for independent evidence.123124125

According to the World Health Organization (WHO):

this generation of HTPs has not been on the market long enough for potential effects to be studied. Conclusions cannot yet be drawn about their ability to assist with quitting smoking (cessation), their potential to attract new youth tobacco users (gateway effect), or the interaction in dual use with other conventional tobacco products and e-cigarettes. Future independent studies should address these effects, as well as the safety and risk of HTPs.4

A new body of evidence is emerging that suggests that HTPs may be more harmful to health than tobacco companies would like us to believe. In May 2017, Auer and colleagues published a research letter in JAMA Internal Medicine which challenged PMI’s claim that IQOS heats tobacco without combustion fire, ash, or smoke, and accused the company of “dancing around the definition of smoke to avoid indoor-smoking bans”.126 According to the authors, PMI has misappropriated the popular, yet scientifically incorrect, perception that combustion releases harmful chemicals and creates smoke. Rather, the authors argue, incomplete combustion (a chemical process known as ‘pyrolysis’) can also produce cancer-causing chemicals. Importantly, the authors demonstrate that pyrolysis occurs in IOQS.126 PMI acknowledges this in its own research.127

In addition, in December 2017 a number of former PMI employees and contractors described to Reuters “a number of irregularities” involving clinical trials that underpin PMI’s application to the FDA.128 Tamara Koval, who worked for PMI from 2012 to 2014 and who was directly involved in these clinical trials, told Reuters that she questioned the quality of the researchers and laboratories contracted to carry out the experiments, and that when she had highlighted an irregularity in one the studies, PMI had excluded her from meetings. Reuters’ own investigations found that PMI had dropped one particular experiment because the basic procedure for obtaining informed consent from trial participants had not been followed. Speaking to the investigator in charge of that particular experiment, Reuters was told that he “knew nothing about tobacco”. Reuters also reported that a second investigator had submitted urine samples exceeding human levels, and a third had told Reuters that he “doesn’t hold such company-sponsored clinical trials in high regard, describing them as ‘dirty’ because their purpose is more commercial than scientific”.128 PMI’s response to the Reuters report was that “all studies were conducted by suitably qualitied and trained Principle Investigators”, and that PMI had “taken steps to address any reported irregularities in our studies”.128

In 2018, researchers at the Center for Tobacco Control Research and Education at the University of California San Francisco (UCSF) published their research into PMI’s HTPs.33  They reviewed leaked internal industry documents relating to the IQOS “precursor” Accord as well as contemporary company documents and communications, and PMI’s MRTP application. They found that:

“PM marketed Accord as a ‘cleaner’ tobacco product in an attempt to address smokers’ growing health concerns without making explicit health claims. While PM communications asserted that Accord reduced users’ exposure to harmful constituents, company scientists and executives consistently stressed to both regulators and the public that such reductions did not render Accord safer.”33  

Their research showed that the design of IQOS (and its marketing statements) were similar to those for Accord, and therefore IQOS was a new product variant, but “without consistent improvements in exposure to aerosol toxic compounds”.33 They concluded that:

“In contrast to PM’s past claims for Accord, PMI now claims in its MRTP application that IQOS reduces health risk. This shift in stance is likely not the result of any toxicological difference between Accord and IQOS, but rather a change in the social and regulatory landscape permitting these claims.”33 

An analysis of IQOS commissioned by the Italian Government also concluded that PMI’s reduced risk claims did not hold up. An investigation in 2020 by the Organized Crime and Corruption Reporting Project (OCCRP) and Italian broadcaster Radiotelevisione Italiana (RAI) found that Italy’s National Health Institute had conducted analysis on HTPs, after being approached by PMI.129130131  The Institute reported its findings to the Italian government after a reduction in tax on HTPs (to 50% of that of combustible cigarettes) had been approved by parliament.130132

In early June 2020, Italy’s Health Ministry released a summary of this research which concluded that:

 “The scientific data presented … is not enough to establish that [IQOS] reduces the risk of the product compared to combustion products with the same conditions of use” (translated by OCCRP from Italian).130

PMI itself stated in its MRTP application to the FDA that:

“It has not been demonstrated that switching to the IQOS system reduces the risk of developing tobacco-related diseases compared to smoking cigarettes”.109133

The 2020 TCRG/STOP briefing provides a more detailed, but accessible, explanation and critique of the FDA’s authorization of IQOS as an MRTP.109

Still a Small Part of the Global Tobacco Business

According to Euromonitor data, the largest and fastest growth in the retail market for HTPs has been in the Asia Pacific region, notably Japan (reaching nearly $8.6 billion in 2019) and to a lesser extent in South Korea (US$1.6 billion).173 However, the value of the market appears to be increasing more slowly in the wider South East Asian region; while the Japanese market increased in value by 12% between 2018 to 2019, the value of the market in South Korea fell slightly. The HTP market now appears to be growing more rapidly in Eastern and Western Europe; Russia and Italy each accounted for over US$1 billion in sales in 2019, with the total value for Russia increasing by nearly 200% from 2018. A number of countries in Eastern Europe have sales of over $100 million, including Ukraine.17

In 2019, HTPs represented just under 2% of the global retail value of all tobacco products (Figure 4). This represents a slight increase from 2018, when the value share was closer to 1.5%. E-cigarettes continue to represent a greater value share than HTPs (2.5% in 2019) and smokeless tobacco accounts for a smaller share, around 1.6%.17 (Note that when excluding China, where heated tobacco products are not yet marketed, the HTP share is closer to 3%, up from 2% in 2018)173

Figure 4: Global retail value of tobacco products, 2019 (Source: Euromonitor International)

Traditional combustible tobacco products still represent the bulk of the market and are likely to do so for the foreseeable future.

Threat to Implementation Framework Convention on Tobacco Control

The WHO and the Secretariat to the WHO Framework Convention on Tobacco Control (FCTC) have warned that the tobacco industry’s HTPs are addictive,134 “in pursuit of profit rather than public health”,135 and should be subjected to the same policy and regulatory measures applied to all tobacco products, in line with the FCTC.134

Regulation of HTPs

At the FCT Conference of the Parties in 2018 (COP 8), the parties agreed to regulate HTPs as tobacco products under the FCTC Articles and guidelines.136 In March 2019, the Secretariat of the WHO FCTC issued an information note, which compiled all Conference of the Parties (COP) decisions related to novel tobacco products, including HTPs.137

Individual countries are at different stages in their regulation of HTPs; some have banned them outright, while some in Europe have allowed their sale under certain regulatory conditions.138139140 For more information see the Global Tobacco Control website.

There were some significant changes to regulation in the late 2019 and early 2020. In December 2019, India passed a law banning HTPs, e-cigarettes and all similar devices.141 In February 2020, Mexico banned the import of HTPs and e-cigarettes by Presidential Decree.142 In June 2020, the Australian government’s Therapeutic Goods Administration (TGA) made an interim judgement rejecting the sale of HTPs, which became final in August 2020, in the face of considerable lobbying from PMI to allow the sale of IOQS in Australia.143144145 The TGA concluded in its final judgement that:

“maintaining the current scheduling for HTPs is necessary to protect public health from the risks associated with introducing a new nicotine product for non-therapeutic use.”144

In September 2019, the FCA Secretariat released a statement urging governments to remain vigilant towards emerging nicotine and tobacco products.146 Tobacco control researchers have pointed out “there is nothing in US law or the FCTC that prevents authorities from prohibiting HTPs”.55

PMI Promotion of HTPs

Even before the FDA granted IQOS “modified exposure” status, there was evidence of PMI promoting their HTP as a reduced risk product outside the US, where regulations on marketing are less stringent.113138147148 The TCRG/STOP briefing identifies the potential for misrepresentation of the partial approval applying to the marketing of IQOS in the US.109 Research from the US in 2020 anticipated PMI’s promotional tactics, concluding that “reduced exposure claims as well as reduced risk claims on PMI’s IQOS product packaging are likely to mislead consumers, especially youth, and thereby endanger public health.”100

On 27 July 2020, the WHO issued a statement reminding parties that “Heated tobacco products are tobacco products” and that, while the US is not a signatory, where countries are signed up to the FCTC, it fully applies to HTPs.149 In relation to health impacts, it stated:

“WHO reiterates that reducing exposure to harmful chemicals in Heated Tobacco Products (HTPs) does not render them harmless, nor does it translate to reduced risk to human health. Indeed, some toxins are present at higher levels in HTP aerosols than in conventional cigarette smoke, and there are some additional toxins present in HTP aerosols that are not present in conventional cigarette smoke. The health implications of exposure to these are unknown.(…) Given that health may be affected by exposure to additional toxins when using HTPs, claims that HTPS reduce exposure to harmful chemicals relative to conventional cigarettes may be misleading.149

The WHO also drew attention to the FDA’s specific conditions requiring monitoring of youth use and exposure, and that PMI must not use the FDA decision to mislead consumers:

“Even with this action, these products are not safe nor “FDA approved.” The exposure modification orders also do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.”149150

In 2020 PMI began quoting the FDA decision in its press releases and media interviews around the world, pushing for a greater acceptance of IQOS, more favourable regulation of HTPs, and to allow their introduction in countries where they are currently, or soon to be, banned. For example, in Hong Kong, various media outlets have published articles in which the FDA decision has been used to advocate against a proposed ban on next generation smoking products.151152

On 1 September 2020 the Mexican Ministry of Health made a public statement referring to PMI’s “aggressive” campaign for IQOS in Mexico, including its misleading use of the FDA decision.153 This statement reiterated the ban on the import of HTPs, and made clear that the Mexican government had not granted IQOS any form of reduced risk status, and that it did not support its use as a tool to stop smoking. It also confirmed that, while the product was already being marketed in Mexico, doing so remained illegal. The Ministry of Health reaffirmed the WHO position; that HTPs are tobacco product, and should be regulated as such, and that any interference in public health by the tobacco industry should be resisted.153

Bath TCRG researchers, in an editorial published in the British Medical Journal (BMJ) in September 2020, warned that the FDA’s decision was likely to lead to “regulatory confusion” in respect of HTPs.154 They reiterated the WHO recommendation to regulate HTPs as tobacco products, and urged the FDA to “make its terminology clearer to ensure products which meet only reduced exposure criteria cannot be misrepresented as reduced harm”.154

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References

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