An electrically-heated smoking system, also known as a heated tobacco product or heat-not-burn tobacco product (HNB),[1] uses an electric heating element to char tobacco,[2] at a lower temperature than a conventional cigarette[3] or pipe.[4][failed verification] The result is a smoke that contains nicotine, other chemicals, and particulates.[1][5] These products may match some of the behavioral aspects of smoking.[6] Some tobacco companies claim these products are less harmful to consumers than other types of cigarettes, but there is no reliable evidence to support these claims.[3][7]
Heat-not-burn products first came to market in 1988, however they were not a commercial success.[3] These products are currently being re-introduced by large tobacco companies.[8]
Health effects
There is not enough research to evaluate the level of harm of these products.[9] A 2016 Cochrane review found that it was unclear whether using these products instead of conventional cigarettes would "substantially alter the risk of harm".[10] Also in 2016, the WHO noted that some scientists believe these products to be as harmful as traditional cigarettes, and stated that no convincing evidence had been presented for industry claims of lowered risk and health benefits. Independent research is not available to support these claims; they are based on industry-funded research.[7] Independent 2018 reanalysis of data from industry research has found deficiencies and omissions in the evidence used to support the industry's claims.[11][5][12]
Carlos Jiménez, director of research on smoking at the Spanish Society of Pneumonology and Thoracic Surgery stated in 2017 that these products are still harmful.[13] Action on Smoking and Health 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.[14] Marketing slogans like "heat-not-burn" cannot be a substitute for science.[15]
The effects of second-hand exposure are unknown.[1]
Addiction and quitting
Such products are believed to be just as addictive as conventional cigarettes.[16] Nearly half of people using these products had never used conventional cigarettes, according to a small survey done in Italy.[17] This has caused concern that the products might cause nicotine addiction rather than reduce harm to those who already smoke.[17]
There is not enough evidence to know if HnB products help with quitting smoking.[18]
Pregnancy
The effects of smoking HnB devices during pregnancy are unknown.[18] During pregnancy and breastfeeding, mothers are advised not to use any products containing nicotine,[19] as nicotine harms the fetus.[20] One 2010 review concluded "Overall, the evidence provided in this review overwhelmingly indicates that nicotine should no longer be considered the ‘‘safe’’ component of cigarette smoke. In fact, many of the adverse postnatal health outcomes associated with maternal smoking during pregnancy may be attributable, at least in part, to nicotine alone".[19]
Nature and function
Nicotine is released from tobacco heated above 140°C.[21] Heating tobacco causes pyrolysis; organic material breaks down, releasing most of the substances found in regular cigarette smoke.[22] At higher temperatures, the carbon increasingly combines with atmospheric oxygen, releasing carbon monoxide and carbon dioxide.[22] It is possible to heat to a temperature hot enough to cause pyrolysis, but not hot enough to oxidize and release the carbon.[22] This ancient process is called charring,[2] and the carbon-rich residue is called char.[23]
HnB products vary, but can heat to these charring temperatures.[22][better source needed] The composition of the smoke is changed by lower temperatures: levels of some substances fall, while levels of others rise.[5] While the nicotine is the main addictive component in tobacco, some pyrolysis products of tobacco are thought to reinforce addiction (such as acetaldehyde, norharman, and harman),[24][25] some of which have been found in lower levels in the smoke of HnB products.[26]
These products are marketed as "heat-not-burn"[27] and "smoke-free".[28] However, independent researchers who tested a common "heat-not-burn" device explicitly disagreed with the claim that they are smokeless,[29][30] arguing that the emitted aerosol is smoke, as it contains pyrolysis products.[31] Independent researchers studying the aerosols produced by heat-not-burn products commonly call those aerosols "smoke".[32] Independent research has also disputed the claim that the products are "heat-not-burn" devices.[2][33]
History
The first commercial heat-not-burn product was the R.J. Reynolds Premier,[34] a smokeless cigarette launched in 1988 and described as difficult to use.[35] Many smokers disliked the taste.[36] 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 a smoke inlcuding aerosolized nicotine.[37] It did require some combustion.[38] In 1989,[39] after spending $325 million,[40] R.J. Reynolds pulled it from the market months later after organisations recommended to the US Food and Drug Administration (FDA) to restrict it or classify it as a drug.[41]
The Premier product concept went on to be further developed and re-launched as Eclipse[39] in the mid-1990s,[42] and was available in limited distribution as of 2015.[43] Reynolds American stated that the Revo was a "repositioning" of its Eclipse.[44] R.J. Reynolds' Revo was withdrawn in 2015.[43]
Philip Morris International (PMI) launched a cigarette in 1998 that was placed into an electronic heating device as Accord.[45] The battery-powered product was the size of a pager.[46] The product was marketed as "low-smoke". Ads claiming reduced risk were drafted, but never released; an attempt was made to get the Surgeon General of the United States to endorse it without requiring long-term studies on its health effects. Few people started using the Accord, and almost all users also continued to use regular cigarettes. The Accord was discontinued in 2006, eight years after it came on the market.[47]
In 2007 PMI launched the Heatbar,[48] which was nearly identical to the Accord.[47] The Heatbar was around the size of a mobile phone and was said to heat specifically designed cigarettes rather than burning them.[49] The only benefit was to lower second-hand smoke, which lead to Heatbar being discontinued.[50] Heatbar did not obtain any significant user reception.[51] Accord and Heatbar are predecessors of PMI's current heat-not-burn tobacco products.[52]
The ubiquitousness of electronic cigarettes and growing dissatisfaction with not providing a throat-hit may present an opportunity for heat-not-burn tobacco products.[3] These products are currently being introduced by large tobacco companies.[8] PMI 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.[53]
Products
-
Electrically-heated cigarette system. a) Charger (left) and cigarette holder (right), b) low-temperature cigarette (left) and holder with cigarette inserted (right), c) Disassembled holder, with heating element visible (left) and the holder's lid (right)
The products are designed to be similar their combustible counterparts.[44] A tobacco stick along with a heating element will provide the user a choice across the different heat-not-burn tobacco products available.[44][clarification needed] 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.[4]
3T
The 3T from Vapor Tobacco Manufacturing was launched in December 2014.[54] The product employs a patented, aqueous system whereby desired components are extracted into water.[55] The liquid is mixed with glycerin and aerosolized producing a smoke without combustion by an electronic heating system.[55] Their organic liquids are made from organic tobacco, organic glycerin, and water.[54]
Glo
In 2016 British American Tobacco (BAT) launched a heat-not-burn product called glo in Japan.[56] glo is battery-powered.[56] It uses a heating element with a tobacco stick.[44] In May 2017 they released i-glo in Canada.[57] The glo iFuse debuted in Romania by BAT in 2015.[44] It uses a cartridge with a tobacco stick and a flavored nicotine liquid.[44] Bonnie Herzog, a senior analyst at Wells Fargo Securities stated that the proposed acquisition of R. J. Reynolds by BAT in 2016 would let them catch up in the technology competition.[58]
IQOS
The introduction of IQOS was announced on 26 June 2014.[59] 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 cigarettes have more nicotine, more tar, and less tobacco. They are heated to a lower temperature, and the kit costs about US$40 more in 2018 dollars.[47] The product is marketed by Philip Morris International (PMI) under the Marlboro and Parliament brands.[60]
Initially launched in 2014 in Nagoya, Japan and Milan, Italy, IQOS is being gradually rolled out to other countries.[61] By end of 2016 it was available in over 20 countries, with expansion plans into several more in 2017 as manufacturing capacity increases.[62] PMI has projected that when 30 billions units are sold, iQOS would increase profits by $700 million.[63] To date, the company claims that total investments made in the development and assessment of these products have exceeded $3 billion.[64] Phillip Morris spent €500 million on iQOS in 2016 alone.[65]
iQOS consists of a charger around the size of a mobile phone and a holder that looks like a pen.[66] The disposable tobacco stick, which looks somewhat like a short cigarette, has been dipped in propylene glycol,[15] is inserted into the holder which then heats it to temperatures up to 350 °C.[45] The smoke released contains nicotine and other chemicals.[6] The amount of nicotine provided may be a little strong for light cigarette smokers.[67] Users have reported less smell and odour on clothing.[38] The smoke generated by iQOS contains substances from pyrolysis and thermogenic degradation that are identical to the constituents found in traditional tobacco cigarette smoke.[15] 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."[68]
One independent study of the iQOS criticized Phillip Morris, saying "Dancing around the definition of smoke to avoid indoor-smoking bans is unethical" and called for more independent research, saying "Smokers and non-smokers need accurate information about toxic compounds released in IQOS smoke. This information should come from sources independent of the tobacco industry".[15] After the study was published, the heads of the three Swiss universities where the authors worked received letters from Phillip Morris, accusing the authors of faulty methodology, and subsequently the researchers were not willing to talk to a journalist.[29] JAMA Internal Medicine, which published the study, described the letters as unusual and smacking of intimidation.[29] Phillip Morris also published an online academic counter-argument.[29]
In December 2016, PMI submitted an multi-million page application[65] to the US FDA for iQOS to be authorized as a modified risk tobacco product.[69] The FDA reviewed Phillip Morris's data, some independent studies, including the May 2017 Swiss paper about toxic compounds in iQOS smoke mentioned above, a December 2017 amendment to the application by Phillip Morris on the same topic, and the FDA's own laboratory testing data.[70]
In January 2018, the FDA advisory panel ruled that Phillip Morris had not shown that their product cut health risks;[71][72] the panel also "expressed concerns about the lack of data" on risk relative to cigarettes.[73] The Campaign for Tobacco-Free Kids criticized the product, saying that it looks like the e-cigarettes which children use the most.[30] IQOS is marketed in stores and packaging which resemble those of high-end smartphones, a strategy expected to appeal to youth by associating it with their interests in new technology.[74]
PMI intends to convert its customers in Japan to using heat-not-burn products.[75] iQOS is sold as an alternative to cigarettes.[76] PMI states that they understand that its iQOS product will be as addictive as tobacco smoking.[14] iQOS is sold with a warning that the best option is to avoid tobacco use altogether.[77]
iSmoke OneHitter
iSmoke OneHitter by iSmoke was launched in 2015.[78] It can be used as a loose-leaf tobacco vaporizer.[79] It has a chamber that can be filled with up to 800-milligrams of tobacco.[79]
Korea Tobacco & Ginseng Corporation
Korea Tobacco & Ginseng Corporation announced on 8 June 2017 that they will launch a heat-not-burn tobacco product in September 2017.[80]
Pax 2
PAX Labs, formerly known as Ploom,[81] sells PAX vaporizers.[82] In 2010 they launched Ploom, a butane-powered product used for the heating tobacco or botanical products.[83] Later models replaced butane heating with an electric system.[84] After its initial partnership with Japan Tobacco was abandoned, the company became known as Pax Labs.[85] The Pax 2 uses loose-leaf tobacco.[44] The surface of the Pax 2 remains cool, while the oven heats to temperatures up to 455 °F.[86] It has four temperature options.[86]
Ploom Tech
In January 2016 Japan Tobacco (JT) released Ploom TECH.[87] JT's Ploom has been withdrawn from the US.[44] The Ploom brand, however, remained with JT and the product itself has been replaced with a different product called Ploom Tech, in which an aerosol passes through a capsule of granulated tobacco leaves.[88] Sales are being expanded throughout Japan in 2017.[89] They intend to spend $500 million to increase their heated tobacco manufacturing capacity by late 2018.[90]
V2 Pro
V2 originally released their vaporizer line named V2 Pro in July 2014.[91] The initial product was named Series 3.[91] Series 3 comes with 3 cartridges including a loose-leaf cartridge, which heats the material by conduction.[92] It comes with a battery and USB changer, among other things.[92] Pro Series 3X also by V2 can be used with dry material.[93] It has three different air flow options that can be adjusted with a slight turn of the mouthpiece.[93] Series 7 comes with a loose-leaf cartridge, among other things.[94] Series 7 lets the user change the temperature by using a single button.[91]
Regulations
In the United States, these products fall under the jurisdiction of the Food and Drug Administration.[4] As of 2016, 19 countries have permitted the sale of iQOS.[15] Advertisement for the iQOS, but not iQOS' tobacco stick, is not regulated under the European Union Tobacco Products Directive.[44] Heat-not-burn tobacco products are not restricted for sale in Israel by the Ministry of Health.[95] Ploom and iQOS are governed by the Tobacco Industries Act regulations as tobacco products in Japan.[96] The Liberal Democratic Party will deliberate over increasing the tax rate for heat-not-burn tobacco products in April 2018.[97] iQOS's refill sticks are not legal for sale in New Zealand by the Ministry of Health.[98] Emerging tobacco products are banned in Singapore by the Ministry of Health.[99] Electronic tobacco products using dry material are regulated as e-cigarettes in South Korea by the Ministry of Health and Welfare.[100] Korea regulates e-cigarettes differently than traditional cigarettes for tax reasons.[101] As a result, iQOS are taxed at a decreased rate, compared to the 75% incurred on normal cigarettes.[101]
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."[14] Tobacco control activist Stanton Glantz stated that the US FDA should halt new tobacco products until tobacco companies stop selling traditional cigarettes.[102] "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.[103]
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Currently, there is also insufficient evidence on the potential effects of second-hand emissions produced by HTPs.
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As previously discussed, products that heat rather than burn are claimed to be less harmful than traditional cigarettes, although these claims of risk reduction are based on industry-funded studies. Independent studies should be conducted to investigate these claims. Convincing evidence has yet to be provided for the claims of risk reduction and health benefits of products that heat rather than burn tobacco [37]. Some scientists consider these heated tobacco products to be just as harmful as conventional cigarettes[38].
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These trends may be of concern, since we have previously shown that nearly half of Italian IQOS users (45%) and over half of the people interested in IQOS (51%) are never smokers. Therefore, such a product may represent, at least in Italy, a gateway for nicotine addiction among never smokers rather than a harm reduction substitution for current smokers
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PMI's MRTP application fails to address the important question of whether the aerosol generation process for IQOS produces toxic substances not found in the smoke of combustible cigarettes, which could have been answered through non-targeted chemical analysis. Combustible tobacco cigarettes reach about 900°C during a puff and smoulder at about 400°C between puffs.[23] The burning process, substances emitted and their levels vary at different temperatures.[38] 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, CO and water.[38] HeatSticks are heated to a maximum of 350°C,[19] a temperature sufficient to enable pyrolytic decomposition of some organic materials. 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.[39–42] In addition, flavouring chemicals in e-cigarettes undergo thermal degradation and contribute significantly to levels of toxic aldehydes emitted in e-cigarette aerosol.[43] Since the constituents of HeatSticks may be different from that of combustible cigarettes, including flavourants and additives, it is plausible that the IQOS aerosol may contain substances not present in tobacco smoke.
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