Heat-not-burn product

E-cigarette emissions machine with heat-not-burn tobacco products.[11] The emissions of four heat-not-burn tobacco products can be generated in parallel in an emissions experiment.[11] The emissions generated are analyzed using appropriate analytical techniques, which allows a comparison of different applications and products.[11]

A 2016 Cochrane review found that it was unclear whether using heat-not-burn tobacco products instead of traditional cigarettes would "substantially alter the risk of harm".[20] As of December 2017, it is impossible to quantify the health risk from using these products.[42] There is very limited information available on their health effects[42] and the available research on their harmfulness is limited.[24] It is not clear what the adverse effects are in the short-term.[47] The long-term effects are unclear.[47] There is a lack of long-term studies.[11] Studies over one year on the effects of exposure to heat-not-burn tobacco products have not been conducted, as of 2019.[48] A limited amount of independent studies have been conducted on heat-not-burn tobacco products, as of 2019.[48]

There are different kinds of heat-not-burn tobacco products available and therefore the effects each kind produces will vary.[49] This creates a challenge for researchers.[49] It is not known how users evaluate the safety of these products.[50] Among those who have tried such products, approximately 50% believe they are safer than traditional cigarettes and the other 50% believe they are just as unsafe as traditional cigarettes.[50]

A 2016 World Health Organization report stated that claims of lowered risk or health benefits for heat-not-burn tobacco products compared with traditional cigarettes are based on industry-funded research, while compelling independent research was not available to support these claims.[40] Studies on human use were wide-ranging and largely affiliated with the manufacturers, as of 2018.[7] Action on Smoking and Health in the UK stated in 2016 that due to "the tobacco industry's long record of deceit" regarding the health risks involving smoking, it is important to conduct independent studies into the health effects of these products.[51]

With an assorted range of electronic cigarettes devices in the UK, it is unclear whether heat-not-burn tobacco products will offer any favorable benefit as another plausible harm reduction product.[41] A 2016 World Health Organization reported noted that some scientists believe that heat-not-burn tobacco products to be as dangerous as traditional cigarettes.[40] A 2018 Public Health England report states that the evidence indicates that heat-not-burn tobacco products may be much safer than traditional cigarettes but less safe than e-cigarettes.[41] Although heat-not-burn tobacco products are probably less dangerous than smoking, it would be better for smokers to completely stop, according to the Committee on Toxicity in 2017.[42]

• 
  Tobacco stick; above, disassembled, below, intact.[11] A: Reconstituted tobacco film, made of dried tobacco suspension.[11] 70% tobacco, humectants (water and glycerin) to encourage aerosol formation, binding agents, and aroma agents.[11] B: Hollow acetate tube.[11] C: Polymer film filter cools the aerosol.[11] D: Soft cellulose acetate mouthpiece, which mimics the feel of a traditional cigarette.[11]

Nicotine is released from tobacco heated above 150 °C.[66] Combustible tobacco cigarettes reach about 900 °C during a puff and smoulder at about 400 °C between puffs.[19] The burning process, substances emitted and their levels vary at different temperatures.[19] Distillation, the process during which nicotine and aromas are transferred from tobacco to smoke, occurs below 300 °C; pyrolysis occurs at about 300 °C–700 °C, entails the decomposition of biopolymers, proteins, and other organic materials and generates the majority of substances emitted in smoke; and combustion occurs above 750 °C and results in the generation of carbon dioxide, carbon monoxide, and water.[19] The temperature the tobacco reaches greatly varies among heat-not-burn tobacco products.[42] It depends on the process used to heat the tobacco.[42] HeatSticks are heated to a maximum of 350 °C, a temperature sufficient to enable pyrolytic decomposition of some organic materials,[19] while the glo iFuse heats tobacco to around 35 °C.[18] Formation of toxic volatile organic compounds, including formaldehyde, acetaldehyde and acrolein, via dehydration and oxidation of the humectants, propylene glycol and glycerin, have been reported in e-cigarette aerosols at similar temperatures as IQOS.[19] In addition, flavoring chemicals in e-cigarettes undergo thermal degradation and contribute significantly to levels of toxic aldehydes emitted in e-cigarette aerosol.[19] Carbon monoxide (CO), nitrogen oxides, soot or tars, and aldehydes in the emissions demonstrate that these products undergo thermal degradation.[18] The solids in the emissions have been called nicotine-free dry particulate matter rather than tar in papers written by people connected to the tobacco industry.[18] Gases, liquid and solid particles are also found in the emissions.[18]

Since the constituents of HeatSticks may be different from that of combustible cigarettes, including flavorants and additives, it is plausible that the IQOS aerosol may contain substances not present in tobacco smoke.[19] The emissions of the IQOS HeatSticks and the IQOS menthol mini-cigarettes contains about three times the amount of water and about half the amount of tar found in the emissions of traditional cigarettes.[18] The IQOS HeatSticks do not generate a flame, they are charred following use.[67] Heat-not-burn tobacco products including IQOS generate smoke.[18] Up until 2016, Phillip Morris International researchers stated their IQOS product produces smoke.[18]

The heat-not-burn tobacco product consists of 3 components with different functions.[11] These include the tobacco stick with processed tobacco, a pen-like heater (holder), in which the tobacco stick is inserted, which is then heated by means of an electrically controlled heating element, and a charger (the charger), which recharges the heater after use.[11] The heat-not-burn tobacco products automatically stops the heating process after 6 minutes or 14 moves, so that pyrolysis products and pollutant release are limited in time as well as by a maximum number of puffs per stick.[11] Heat-not-burn tobacco products may not generate side-stream smoke because they do not fully combust, but the temperatures reached are sufficient for pyrolytic reactions to happen.[10] There are devices that demonstrate pyrolysis or combustion, but research has not determined whether it is pyrolysis or combustion.[18] The tobacco stick contains a compressed tobacco film as well as several filter elements.[11] The tobacco film consists of a dried tobacco suspension that has been rolled up into a paper-thin brown tobacco foil.[11] This consists of about 70% tobacco as well as humectants, binders and flavorings.[11] Water and glycerin are used as humectants to prevent drying out and to promote aerosol formation upon heating.[11] The filter elements consist of 2 independent systems: A polymer film filter that cools the aerosol, followed by a soft cellulose acetate mouthpiece filter that mimics the sensory aspects of a traditional cigarette.[11]

Tobacco film (right side) following use.

Heat-not-burn tobacco products are a battery-powered systems that produce nicotine-containing emissions by heating tobacco.[11] For this purpose, tobacco sticks are placed in a corresponding heater and heated to about 250–350 °C (around 500 °F.[35]).[11] This results in nicotine-containing emissions, which are inhaled via a mouthpiece with a filter segment.[11] They are hybrids between electronic and conventional cigarettes: on one hand, they are equipped with a device that heats the product, without reaching combustion, to generate aerosol (i.e., a sort of "cold smoke"); on the other hand, the product used is not a liquid containing nicotine, but "real" tobacco.[62] There are products that have a time limit, so that the user is forced to inhale the nicotine within 3.5 minutes to 10 minutes prior to the device turning off.[18] This function helps support peaks of blood nicotine, resulting in an increased nicotine dependence.[18]

There are three general types of heat-not-burn tobacco products.[42] One immediately heats processed tobacco to generate aerosol.[42] Another uses processed tobacco that is heated in an aerosol.[42] Then there are ones where the aerosol goes over processed tobacco to give a flavor to the aerosol.[42] Heat-not-burn tobacco products heat tobacco leaves at a lower temperature than traditional cigarettes.[34] Heat-not-burn tobacco products usually heat up tobacco, rather than use liquids.[68] In contrast, e-cigarettes heat liquids that can contain nicotine.[31] Another type of heat-not-burn tobacco product is the loose-leaf tobacco vaporizer that entails putting loose-leaf tobacco into a chamber, which is electrically heated using an element.[30] Some use product-specific customized cigarettes.[14] There are devices that use cannabis.[39] They are not e-cigarettes.[14] They can overlap with e-cigarettes such as combining an e-cigarette and a heat-not-burn tobacco product, for using tobacco or e-liquid.[37]

Steam Hot One, a Japanese variant of the Eclipse made by Japan Tobacco.

Philip Morris' Heatbar pictured without a specifically designed cigarette.

As early as the 1960s, the tobacco companies developed alternative tobacco products with the goal of supplementing the cigarette market with products.[44] The first commercial heat-not-burn product was the R. J. Reynolds Premier,[69] a smokeless cigarette launched in 1988 and described as difficult to use.[27] Many smokers disliked the taste.[70] It was not popular with users when it was test-marketed in Arizona and Missouri.[71] It was shaped like a traditional cigarette, and when heated the smoldered charcoal moved past processed tobacco containing more than 50 percent glycerin to create an aerosol of nicotine.[72] It did require some combustion.[73] In 1989,[74] after spending $325 million,[75] R. J. Reynolds pulled it from the market months later after the American Medical Association and other organizations recommended to the US Food and Drug Administration (FDA) to restrict it or classify it as a drug.[76]

The Premier product concept went on to be further developed and re-launched as Eclipse[74] in the mid-1990s,[77] and was available in limited distribution as of 2015.[78] Eclipse was promoted using viral marketing.[74] Reynolds American also introduced a brand called Revo and stated that the Revo was a "repositioning" of its Eclipse.[79] R. J. Reynolds' Revo was withdrawn in 2015.[78] The Steam Hot One was sold in Japan by Japan Tobacco.[80]

In October 1998, Philip Morris launched the Accord in the US.[21] A specialized cigarette was designed to be used with the electric heating system.[21] Also in 1998, the company launched Accord in Osaka, Japan, calling it Oasis.[21] The battery-powered product was the size of a pager.[81] The product was marketed as "low-smoke".[21] Advertisements stating reduced risk were drafted for Accord in the US, but were never released.[21] An attempt was made in 2007 by Kenneth Podraza, who was the Vice President of Research and Development at Philip Morris in the US, to get the Surgeon General of the United States to endorse it.[21] It has not been shown that the Surgeon General replied to Podraza's letter.[21] Few people started using the Accord, and most users also continued to use traditional cigarettes.[21] The Accord ceased production in 2006, eight years after it came on the market.[21]

In 2007 Philip Morris International launched Heatbar,[82] which was very similar to the Accord.[21] The Heatbar was around the size of a mobile phone and was said to heat specifically designed cigarettes rather than burning them.[83] The only benefit was to lower second-hand smoke, which led to Heatbar being discontinued.[84] Heatbar did not obtain any significant user reception.[85] Accord and Heatbar are predecessors of Philip Morris International's current heat-not-burn tobacco products.[86] Heat-not-burn tobacco products were not a commercial success, and most of them were quickly taken off the market following their debut.[35]

In years leading up to 2018, increased tobacco control measures have directed the tobacco industry to develop alternative tobacco products, such as heat-not-burn tobacco products.[11] There has been a global decline in tobacco consumption that, if continued, will negatively impact the tobacco industry's profits.[44] This decline led the industry to invent and market new products, such as heat-not-burn tobacco products.[44] The introduction of these heat-not-burn tobacco products may also have been a response to the growing popularity of e-cigarettes beginning around 2007 after independent companies introduced them before the major multinational tobacco companies entered the e-cigarettes market.[44] Furthermore, the global decline of cigarette consumption and decrease in adult smoking prevalence (from 24% in 2007 to 21% in 2015), combined with the success of tobacco control, including implementation of the WHO Framework Convention on Tobacco Control, may also have led the tobacco companies to consider alternative products to protect their profits and political interests.[44] The ubiquitousness of e-cigarettes and growing dissatisfaction with not providing a throat-hit may present an opportunity for heat-not-burn tobacco products.[35] These products have been introduced by large tobacco companies.[45] They are developed by several tobacco companies.[87] Philip Morris International anticipates a future without traditional cigarettes, but campaigners and industry analysts call into question the probability of traditional cigarettes being dissolved, by either e-cigarettes or other products like IQOS.[88]

• 
  Heat-not-burn tobacco system. a) Charger (left) and holder (right), b) Tobacco stick (left) and holder with tobacco stick inserted (right), c) Disassembled holder, with heating element visible (left) and the holder's lid (right).[11]

The products use a heating system where the tobacco is heated and aerosolized.[14] In addition to nicotine, they contain additives not derived from tobacco, and are frequently flavored.[14] The evidence indicates that the concentrations of nicotine in mainstream heat-not-burn tobacco products aerosol are less than what is found in cigarette smoke.[53] Smokers regularly reported heat-not-burn tobacco product use to be less satisfying than smoking a cigarette.[43] The heat-not-burn tobacco products that were tested provided more nicotine in the aerosol than a cigalike e-cigarette but not as much nicotine compared with a tank style e-cigarette.[43] They are designed to be similar to their combustible counterparts[89] and they provide some of the behavioral aspects of smoking.[36] These products replicate the oral inhalation and exhalation, taste, rapid systemic delivery of nicotine, hand-to-mouth feel and throat hit sensations (depending on the temperature) that are similar to smoking traditional cigarettes.[34] Heat-not-burn products aim for a niche between combustible tobacco smoking and e-cigarettes that aerosolize nicotine suspended in humectants.[7] There are different types of heat-not-burn tobacco products in the marketplace.[17] Some examples include products that use tobacco sticks such as glo and IQOS, or products that use loose-leaf tobacco such as Pax and Ploom.[14]

eTron 3T

eTron 3T organic red, gold and menthol products.

The eTron 3T was initially launched as a disposable e-cigarette by Vapor Tobacco Manufacturing in December 2014.[90] The product employs a patented system whereby tobacco is ground and used to make a water-based extract.[91] The liquid and tobacco extract is mixed with glycerin and aerosolized by an electronic heating system.[91] Their organic liquids are made from organic tobacco, organic glycerin, and water.[90] They are sold in 15 ml bottles.[92] The heat-not-burn device uses nicotine and tobacco.[93] The taste is similar to tobacco, according to the company.[90] They also sell rechargeable e-cigarettes that contain the patented tobacco extract.[93]

IQOS

IQOS, consisting of charger, holder, and tobacco stick.

The introduction of IQOS (/ˈaɪkoʊs/ EYE-kohs[102]) was announced in June 2014.[103] The product is marketed by Philip Morris International under the Marlboro and Parliament brands.[104] Although it is marketed as a novel product, it is very similar to the "Accord" product released by the same company in 1998; however, the IQOS sticks have more nicotine, more tar, and less tobacco.[21] They are heated to a lower temperature, and the kit costs about US$40 more in 2018 dollars.[21]

Initially launched in 2014 in Nagoya, Japan, and Milan, Italy, IQOS is being gradually rolled out to other countries.[105] As of October 2019, IQOS is available in 49 countries.[106] Philip Morris International has projected that when 30 billions units are sold, IQOS would increase profits by $700 million.[107] In October 2018, Philip Morris International introduced a less expensive version of IQOS called IQOS 3 in Tokyo, Japan.[108] The IQOS 3 Multi was also launched, which is capable of multiple consecutive uses.[109]

The IQOS product consists of a charger around the size of a mobile phone and a holder that looks like a pen.[110] The packaging of IQOS is similar to iPhones and other upscale smartphones.[111] The disposable tobacco stick[112] called HeatSticks or HEETS in some places they are sold,[113] is described as a mini-cigarette.[18] The sticks contain processed tobacco and has been soaked in propylene glycol.[112] The stick is inserted into the holder which then heats it to temperatures up to 350 °C.[114] The amount of nicotine provided may be a little strong for light cigarette smokers.[115] The sticks are available in regular, balanced regular, menthol and mint flavor.[115] Users have reported less smell and odor on clothing.[73] There is a limited amount of research on the effect of IQOS on the user's health.[116] A 2017 review found "little research on what substances are released after the device heats the tobacco-based paste. The physical effects on users are also not yet known."[117] The emissions generated by IQOS contains the identical harmful constituents as tobacco cigarette smoke, including volatile organic compounds at comparable levels to cigarette smoke, polycyclic aromatic hydrocarbons at vast various ranges, and carbon monoxide.[3] Each of these substances, on the basis of rigorous research of cigarette smoke, are known to result in significant harms to health.[3] According to Netherlands National Institute for Public Health and the Environment, IQOS is "harmful to health, but probably less harmful than smoking tobacco cigarettes."[118]

On December 5, 2016,[119] Philip Morris International submitted a multi-million page application[120] to the US FDA for IQOS to be authorized as a modified risk tobacco product.[119] The advisory panel appointed by the US FDA reviewed Philip Morris International's application in January 2018.[121] The advisory panel made recommendations about the application to the FDA in January 2018,[121] though the review for these applications is still ongoing.[122] In March 2017, Philip Morris International submitted to the US FDA for a premarket tobacco product application regarding its IQOS product.[123] In December 2017, Reuters published documents and testimonies of former employees detailing irregularities in the clinical trials conducted by Philip Morris International for the approval of the IQOS product by the US FDA.[124] The FDA announced permission for the sale of IQOS in the US on April 30, 2019.[125] This permission also requires the company to follow strict marketing restrictions.[125] IQOS formally launched in the US in October 2019.[106]

Heat-not-burn tobacco products are being introduced in markets around the world, as of 2017.[155] Since October 2019, heat-not-burn tobacco products were sold in at least 49 countries.[106] As of 2017, the market for such products is anticipated to expand by 60% over the next 10 to 15 years.[32] They are globally not as popular as the e-cigarette.[34] As of 2018, the IQOS is the most popular product.[34] The IQOS is allowed to be sold in the US, as of April 30, 2019.[125]

As of April 2018, the industry was rapidly introducing new heat-not-burn tobacco products.[44] As of January 2018, British American Tobacco's iFuse is available in Romania, Japan, Switzerland, Canada, South Korea, and Russia.[44] As of January 2018, Japan Tobacco International's Ploom TECH's is available in Japan and Switzerland.[44] As of January 2018, KT&G Corp.'s lil is available in South Korea.[44] As of January 2018, Philip Morris International's IQOS is available in Canada, Guatemala, Colombia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Kazakhstan, Lithuania, Monaco, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Switzerland, Ukraine, UK, South Africa, South Korea, Japan, and New Zealand.[44] Heat-not-burn tobacco products were first sold in Japan.[156] Several heat-not-burn tobacco brands are marketed in Japan since 2014.[155] Japan is the largest market for heat-not-burn tobacco products.[157] The share of the market in South Korea for heat-not-burn products has surged at least five-fold during the last two years leading up to 2019.[158] As of early 2018, these products are not sold in France.[18]

Tobacco industry leaders have predicted heat-not-burn tobacco products are poised to further displace traditional cigarette smoking and, by extension, tobacco control strategies typically framed around cigarettes.[155] Yet, little is known about the popularity of these products.[155]

Heat-not-burn (heated tobacco) searches originating in Japan have experienced tremendous growth.[155] Since the introduction of Philip Morris International's IQOS brand in select Japanese cities in November 2014, searches for heat-not-burn (heated tobacco) products have increased substantially.[155] Average monthly searches rose 1,426% (95%CI: 746–3,574) between the first (2015) and second (2016) complete years heat-not-burn tobacco (heated tobacco) was marketed.[155] Queries for heat-not-burn (heated tobacco) products continued to grow an additional 100% (95%CI: 60–173) between the products second (2016) and third years on the market (Jan-Sep 2017).[155] In practical terms, there are now between 5.9 and 7.5 million heat-not-burn (heated tobacco) related Google searches in Japan each month based on the latest search estimates for September 2017.[155] Moreover, forecasts relying on the historical trend suggest heat-not-burn (heated tobacco) searches will increase an additional 32% (95%CI: -4 to 79) during 2018, compared to current estimates for 2017 (January–September), with further growth expected.[155]

Queries for heat-not-burn (heated tobacco) in Japan occur more frequently than queries for e-cigarettes in the United States, with the Japanese heat-not-burn queries first eclipsing e-cigarette queries in April 2016.[155] Further, the change in average monthly queries for heat-not-burn (heated tobacco) in Japan between 2015 and 2017 was 399 (95% CI: 184–1,490) times larger than the change in average monthly queries for e-cigarettes in the Unites States over the same time period, increasing by 2,956% (95%CI: 1,729–7,304) compared to only 7% (95%CI: 3–13).[155] These results indicate that interest in heat-not-burn (heated tobacco) may outpace interest in e-cigarettes (in areas where they are introduced) not just now but for years to come.[155]

• 
  Google searches for heat-not-burn tobacco (heated tobacco) outpace past rise of electronic cigarettes.[155] The above figure shows the Relative Search Volume (scaled from 0–100 and adjusted for number of total Google search volumes per month in Japan and the USA) for heat-not-burn (heated tobacco) and e-cigarette products.[155]

Demand for heat-not-burn tobacco products presents a host of tobacco control challenges similar to e-cigarettes and new challenges specific to these products.[155] Heat-not-burn tobacco products have been advertised as reduced-risk tobacco products in their Japanese test market, and these marketing messages will undoubtedly contaminate other markets even where such messaging is banned.[155] Tobacco control advocates will have to develop strategies to both discover and then disseminate messages about the health risks associated with these products.[155] Further, tobacco control advocates will have to consider making adjustments to existing tobacco control policies so that they apply to heat-not-burn tobacco products.[155] For example, policy makers want to extend existing indoor smoking bans to include the emissions from heat-not-burn tobacco products, whether to stigmatize their use or protect bystanders from potentially hazardous emissions.[155]

Temporary smoking room and a sales promotion of glo at the 2016 Sendai Pageant of Starlight in Kōtōdai-kōen Park.

The term "heat-not-burn" refers to tobacco heated (at ~350 °C) by an electrically-powered element or carbon, not combusted (at ~800 °C).[34] Terms used in marketing of cigarette-like products that "heat rather than burn" are referring to the product as "reduced risk" and "innovative".[17] Marketing slogans like "heat-not-burn" cannot be a substitute for science.[112] The tobacco industry has described them as "not-burned" (heat-not-burn), although it has backtracked from this claim, as of 2018.[18] Heat-not-burn tobacco products are not typically marketed as a harmless substitute to smoking.[50] The IQOS product has been advertised as emitting "no smoke".[159] This advertisement claim is not a replacement for science.[3] These products are marketed as a "smoke-free" alternative to traditional cigarettes, and promoted as a way to lower risk from smoking.[29] It is expected that the promotion associated with these products will worsen the worldwide tobacco risk.[18]

Companies are using similar strategies previously used for traditional cigarettes.[160] They are marketed through a variety of outlets.[160] This includes celebrities endorsing them.[160] "The tobacco industry has opened heat-not-burn product flagship stores, cafes and sponsored public events such as concerts and car races around the world, which is alarming," said Judith Mackay, director of the Asian Consultancy on Tobacco Control.[160]

Internal documents and statements by Philip Morris International researchers have contradicted Philip Morris International's claims about reduced harm in regard to the IQOS product.[21] For example, in 2018, four Philip Morris International researchers who no longer work for the company stated that the lowered levels of certain substances produced by the IQOS product does not automatically translated into the product being safer, but Philip Morris International states the IQOS is safer than traditional cigarettes in part as a result of levels of 58 substances were lower in the IQOS aerosol than found in cigarette smoke.[21]

Philip Morris International has been intensively promoting its IQOS product in Europe and Asia, as of 2017.[117] Outside of an IQOS retail shop in Canada, marketing included a display sign with the message, 'Building a Smoke-Free Future'.[161] Philip Morris International intends to convert its customers in Japan to using heat-not-burn products.[162] The IQOS products are sold as an alternative to regular cigarettes.[163]

There has been significant controversy surrounding the marketing and use of these products.[164] The tobacco companies are using a series of claims in the marketing of heat-not-burn tobacco products.[44] Both in websites and statements to the media and investors, heat-not-burn tobacco products are presented as less harmful but not risk-free.[44] In a few instances, marketing materials claim that heat-not-burn tobacco products are potentially helpful to smokers who want to quit.[44] Some media accounts of product launches state that heat-not-burn tobacco products reduce the levels of harmful tobacco components by 90%–95% compared with traditional cigarettes, while others emphasise the lack of odor or visible emissions as part of marketing campaigns.[44] As of April 2018, there is no evidence to confirm this claimed 90%–95% lower level of harm.[44] Other marketing claims highlight that these products produce no smoke, that is, are smoke-free.[44] Implied in these claims, in advertisements and stores globally, is that smokers should switch from traditional cigarettes to these new, allegedly less harmful, products.[44] The introduction of the latest generation of heat-not-burn tobacco products appears to be the latest chapter in the decades-old tobacco industry strategy of working to create partnerships with governments and health advocates, presenting these alleged 'harm reduction' products as an option to address the tobacco epidemic.[44]

The tobacco industry's use of the 'harm reduction' framework also serves to fracture the tobacco control movement, leaving it without a unified voice to communicate with the public, the media and with policy makers on the strategies to advance tobacco control.[44] The concept of harm reduction has traditionally been embraced in several public health fields such as clean needles for injectable drug use and has been explored by some tobacco control experts in the past, with enthusiasm for the possibility of harm reduction growing with the widespread availability of e-cigarettes in certain markets.[44] The tobacco industry frames harm reduction as a common ground with health advocates and a possible entry point to influence legislation and regulation of tobacco products.[44]

The tobacco companies use heat-not-burn tobacco products as part of their broader political and public relations activities to position them as 'partners' to address the tobacco epidemic rather than as the vectors that are causing it.[44] This is a similar strategy previously used by the tobacco industry to promote itself as a partner of public health in reducing the harms of tobacco, while obfuscating the scientific evidence pointing that harm reduction is achieved through tobacco control policies that decrease consumption.[44]

Current smoking bans may not have been extended to include such products.[46] In the majority of the countries in which they have been sold, heat-not-burn tobacco products have been taxed at a lower rate than traditional cigarettes.[165] Tobacco companies have used these products to seek exemptions and relaxations of existing tobacco control policies.[166] Heat-not-burn tobacco products are used as an attempt by tobacco companies to influence regulatory policy to sustain and increase their clientele in the midst of decreasing cigarette usage.[166]

In the United States, these products fall under the jurisdiction of the Food and Drug Administration as amended by the Family Smoking Prevention and Tobacco Control Act of 2016.[30] "There is concern that heat-not-burn tobacco will skirt local ordinances that prevent smoking in public areas," Mitchell H. Katz, director of the Los Angeles County Health Agency, wrote in 2017.[46] Action on Smoking and Health stated in 2016 that "unless and until independent evidence shows that IQOS and similar products are substantially less harmful than smoking then these products should be regulated in the same way as other tobacco products."[51] Tobacco control activist Stanton Glantz stated that the US FDA should halt new tobacco products until tobacco companies stop selling traditional cigarettes.[167] It is recommended that indoor-smoking bans for traditional cigarettes be extended to heat-not-burn tobacco products.[112] It is recommended that marketing of these products, and claims being made about them, should be regulated.[44]

Advertisement for the IQOS product itself is not regulated under the European Union Tobacco Products Directive.[89] Advertising for IQOS' tobacco stick may fall under the European Union Tobacco Products Directive.[89] The UK government has been looking into creating a separate category for taxing heat-not-burn tobacco products.[68]

Due to the alleged belief in heat-not-burn tobacco harm reduction in Italy, these products are exempted from the fiscal regimes of tobacco products.[62] Heat-not-burn tobacco products enjoy the same tax reduction as e-cigarettes, which is half that of traditional cigarettes.[62] Moreover, the enforcement of various tobacco control regulations is only minimally adopted for heated tobacco products in Italy.[62] First of all, health warnings are required to cover only 30% of the heat-not-burn tobacco product packaging (instead of 65% for traditional cigarettes), without pictorial images.[62] Second, comprehensive smoke-free regulations prohibiting smoking in all public places and workplaces do not apply to heat-not-burn tobacco products.[62] Finally, advertising and promotions are not banned for these new products.[62] This is evident by the presence in several strategic Italian cities of the "IQOS embassy" and "IQOS boutique", which are fancy concept stores where IQOS is promoted as a status symbol and people can try it for free.[62] Therefore, the most recognized tobacco control policies (i.e., price/tax increase, smoking bans, advertising bans, and health warnings) have been compromised for heat-not-burn tobacco products in Italy.[62]

Heat-not-burn tobacco products are not restricted for sale in Israel by the Ministry of Health.[168] Justice Ministry in Israel agreed with the view of three voluntary organizations that the IQOS is a tobacco product, and the product should be regulated in the same manner as tobacco products.[169] In Israel IQOS are now taxed at the same rate as traditional cigarettes.[170]

Ploom, IQOS, and glo fall under the Tobacco Business Act as tobacco products in Japan because they consist of tobacco leaf.[57] Ploom and IQOS are governed by the Tobacco Industries Act regulations as tobacco products in Japan.[59] The Liberal Democratic Party will deliberate over increasing the tax rate for heat-not-burn tobacco products in April 2018.[171]

Electronic tobacco products using dry material are regulated as e-cigarettes in South Korea by the Ministry of Health and Welfare.[172] Korea regulates e-cigarettes differently than traditional cigarettes for tax reasons.[173] As a result, IQOS are taxed at a decreased rate, compared to the 75% incurred on normal cigarettes.[173] Emerging tobacco products are banned in Singapore by the Ministry of Health.[174] China plans to pass legislation to ban the sale of these products to minors, as of 2019.[175]

After IQOS launched a marketing campaign in New Zealand in December 2016, the Ministry of Health stated in 2017 that the refill sticks are not legal for sale in New Zealand under the Smoke-free Environments Act 1990.[176] A representative for the company in New Zealand stated that IQOS product complies with the Smoke-Free Environments Act.[177] Three meetings between Ministry of Health officials and people from the tobacco industry were held from May 30, 2017 through June 2, 2017 to "discuss regulation of new tobacco and nicotine-delivery products".[178] Later on, in August 2017, the government stated they would initiate a review process before products are sold for heat-not-burn tobacco products such as IQOS.[178] In 2018, Philip Morris International and the Ministry of Health were in a court over the legality of selling IQOS in New Zealand.[179] A New Zealand court decided in March 2018 that the HEETs sticks used in the IQOS product are legal to sell in New Zealand.[180] Individuals can import heat-not-burn tobacco products to New Zealand for personal use.[181] As of 2019, 49 countries have permitted the sale of IQOS.[106]

• "WHO Report on the Global Tobacco Epidemic, 2019" (PDF). World Health Organization. July 2019. pp. 1–209.
• McNeill, A; Brose, LS; Calder, R; Bauld, L; Robson, D (February 2018). "Evidence review of e-cigarettes and heated tobacco products 2018" (PDF). UK: Public Health England. pp. 1–243.
• "Regulatory Impact Statement: Regulation of smokeless tobacco and nicotine-delivery products" (PDF). Ministry of Health (New Zealand). 2017. pp. 1–52.
• "Further development of the partial guidelines for implementation of Articles 9 and 10 of the WHO FCTC" (PDF). World Health Organization. 12 July 2016. pp. 1–11.
• "Alternatieve tabaksproducten: harm reduction?" [Alternative tobacco products: harm reduction?] (PDF). Netherlands National Institute for Public Health and the Environment. 2016. pp. 1–66.

• Media related to Heat-not-burn products at Wikimedia Commons