Governments are recognizing the potential of smoke-free products
Although smoke-free products are subject to heavy restrictions in some countries, including bans, a growing number of forward-thinking governments have recognized that smoke-free products can be a better alternative to combustible tobacco for smokers that do not quit, and have factored this into their policy. These governments are complementing traditional tobacco control measures (i.e., those intended to discourage initiation and encourage cessation of smoking) with a harm-reduction approach (i.e., providing adults who would otherwise continue to smoke with information about—and access to—scientifically substantiated smoke-free alternatives to accelerate the move away from cigarettes).
New Zealand
Having set the ambitious target of reducing smoking rates to below 5 percent by 2025, the New Zealand government created the Smokefree Aotearoa 2025 Action Plan which recognized that “the emergence of vaping products over the last decade or so has changed the possibilities for people who smoke. Those who are not ready to quit, or are unable to, now have an alternative at much less cost and risk to health.”
The plan sets out actions aimed at establishing a risk-proportionate regulatory framework that differentiates between smoked tobacco products and vaping products. “We will not achieve our goal of Smokefree 2025 until our current regulatory settings reflect a more risk-proportionate framework. We can ensure this by making smoked tobacco products more regulated and less available than vaping products, given their greater health impact.”
The Smokefree Environments and Regulated Products Act, as amended in 2020 to regulate vaping products (e-cigarettes and heated tobacco devices), aimed to achieve a careful balance—preventing initiation by youth and non-smokers, while also recognizing that vaping products are less harmful than smoked tobacco products, and that smokers should be supported to switch if they do not quit.
As such, the law explicitly exempts certain oral and written communications about vaping products from the tobacco advertising prohibition, when they are aimed at encouraging smokers to switch from smoking to vaping. Labeling restrictions and health warnings for e-cigarettes and heated tobacco products are also different to those applied to smoked tobacco products—for example, plain packaging is only required for smoked tobacco products. Furthermore, while flavoured smoked tobacco products are prohibited, flavoured vaping products may be sold in specialized vaping stores.
As official commentary from the NZ Parliament’s Health Select Committee explained: “The bill acknowledges that vaping products and heated tobacco products have lower health risks than smoking, and aims to support smokers to switch to these less harmful products. […] The bill also recognizes that many smokers need support and advice to successfully move to less harmful alternatives, so the Bill allows for the provision of information and advice for those wishing to switch from smoking to vaping.”
United States of America
In July 2017, the U.S. Food and Drug Administration (FDA) announced a new strategic plan to address smoking by increasing restrictions on cigarettes and by allowing “greater flexibility” for alternative non-combusted products. According to then-FDA Commissioner Scott Gottlieb, “Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts.”
The U.S. takes an evidence-based approach to new products, requiring manufacturers to provide extensive information, including scientific studies and market research, for the FDA to verify that placing the product on the market is “appropriate for the protection of the public health.”
U.S. law also allows a manufacturer to submit applications for the FDA to evaluate whether a tobacco product may be marketed as modified or lower risk. This is the Modified Risk Tobacco Product Application (MRTPA) process. Modified Risk orders have been granted to Swedish Match for its “General” brand of snus, an oral smokeless tobacco product; to Philip Morris International for two variants of its tobacco heating system IQOS; and to 22nd Century Group Inc. for its very low nicotine content (VLNC) combusted cigarettes.
Philippines
In 2018, the Philippines House of Representatives adopted a resolution “urging the Department of Health to promote harm reduction measures as part of its National Tobacco control strategy, particularly the use of electronic cigarettes as an alternative for smokers.”
In 2022, the Vaporized Nicotine and Non-Nicotine Products Regulation Act entered into force, creating a separate regulatory framework for vaporized nicotine and non-nicotine products, such as e-cigarettes, heated tobacco products (HTPs) and other novel tobacco and nicotine products. The regulation declares support for harm reduction as state policy by including “reduce the harm from smoking” in the Act’s Declaration of Policy.
The Act provides definitions for novel tobacco and nicotine products based on lack of combustion, allows communication about non-combusted alternatives targeted at adult smokers to facilitate switching, requires the registration of these products as novel consumer goods, sets technical standards for safety, consistency, and quality of these products based on international standards, and contains provisions on preventing youth access to these products.
Importantly, the regulations create a pathway for products that will be marketed with an explicit reduced risk statement to be authorized by the Philippine FDA.
Greece
In November 2019, the Greek Government presented the National Action Plan against Smoking that strengthens and supports the actual implementation of the anti-smoking law (L. 4633/2019), declaring harm reduction as the fourth pillar of its anti-smoking strategy along with prevention, elimination of second-hand smoking, and cessation support. This amendment allows communication of science-based claims for novel products.The Greek Government legislated the fourth pillar in July 2020, stating the objective “of achieving maximum harm reduction for active and passive smokers with the aid of new technologies is added to the policies of prevention at a young age, the cessation of smoking and the protection from passive smoking.”
Law 4715/2020 established Tobacco Harm Reduction as an additional tool for addressing smoking, recognizing the right of citizens to access information about special properties of certain tobacco products such as non-combusted tobacco products and the communication of reduced-risk messages subject to a strict procedure of scientific assessment led by a specialized committee.
In 2023, following the scientific evidence submitted by our Greek affiliate, the Greek Ministry of Health approved a reduced toxicity claim to be used for communication about PMI’s heated tobacco product (HTP) variants when used together with our tobacco heating system, commercialized as IQOS.
Czech Republic
In 2019, the Czech Government approved the National Strategy for Prevention and Harm Reduction with regards to Addictive Behaviors 2019-2027.
The Strategy presents the Government’s approach to addressing addictions on topics such as tobacco, alcohol, illegal substances, opioids and gambling, outlining the “minimization of risks and harms” as a strategic area of modern policy. Action plans based on the strategic document were developed in 2019 and 2022.
In the Action Plan for 2019-2021, the following actions with regard to tobacco policy were outlined:
- The Ministry of Finance was tasked to “Regularly increase excise duty on tobacco products while respecting the differentiation according to the degree of harmfulness of each product for the society.”
- The Ministry of Health and expert associations were tasked to “Prepare and approve the revision of the current Recommendations for treatment of tobacco addiction in the area of harm reduction.”
- The Ministry of Health and Ministry of Agriculture were tasked “At the international level in the area of tobacco control to support the inclusion of the harm reduction principle where the measures are scientifically substantiated and do not undermine public health especially among kids, youths and non-smokers.”
The Action Plan 2022-25 was presented to the Parliament in December 2022. Although not adopted yet, the plan explicitly states “it is necessary to propose a legislative framework favouring less risky tobacco alternatives, nicotine and related products, and thus reduce the incidence of smoking cigarettes and tobacco products with burnt tobacco, and thus minimize the effects of smoking on population health in the Czech Republic.”
It further states that the goal is “to appropriately set the taxes (price) of alternative tobacco products and nicotine products in relation to the price of smoking tobacco products, and economically thus motivating smokers to switch to less risky tobacco alternatives.”
Risk proportionate taxation and regulation principles have also been incorporated in the Government’s Manifesto adopted in January, 2022. The document specifically states:
- “Excise duties will take harmfulness into account.”
- “In addressing addictions, the Government will pursue a policy based on balanced and scientifically proven concept of risk prevention and harm reduction.”
- “The regulation of addictive substances will correspond to the degree of their harmfulness.”
Switzerland
In 2021, the Swiss Parliament adopted a new Tobacco Products Law regulating novel tobacco and nicotine products. The main features of the law included dedicated product categories for smoke-free products (such as e-cigarettes and HTPs) and smokeless health warnings for products that do not combust, as well as allowing manufacturers to communicate factual, non-misleading science-based communications for non-combusted products on product packaging, except claims on curative, lenitive, or preventive effects, amongst others.
Cyprus
The Protection of Health (Tobacco Control) Law of 2017 in Cyprus provides rules for the “… approval for the use of accompanying indications according to which the use of a novel tobacco product presents reduced risk or harm for health compared to conventional tobacco products.”
Portugal
The Portuguese Tobacco Law adopted in 2017 (and revised in 2023) recognizes harm reduction as a viable solution for adult smokers who do not quit: “Regardless of their legal nature, the health services, particularly health centres, hospitals, clinics, doctors’ surgeries and pharmacies, should promote and support health information and education for the citizens in respect of the ill effects of tobacco consumption and of the importance of prevention as well as of putting an end to tobacco consumption, through campaigns, programmes and initiatives directed at the population in general or at specific groups, particularly children and youths, pregnant women, parents, women of fertile age, the sick, teachers and other workers, and also, and exclusively to adult smokers that are not successful with cessation therapies, about the existence of alternatives that are acknowledged by the Directorate-General of Health, as of entailing harm and risk reduction.”
Slovakia
The Government Manifesto, adopted in 2023 by the Parliament, states support for harm reduction with respect to health policy.
“The Government will ensure the development, protection, and support of the public health of the entire society in Slovakia in the form of effective prevention and targeted programs. We will focus on prevention and harm reduction as a[n] interministerial topic and multidisciplinary issue, which is crucial from the point of view of improving the health status of citizens, as well as the sustainability of the health system. Part of the comprehensive approach of the care for the health of the citizens will also be the focus on the issue of the health determinants and addictions...”
“... This comprehensive approach will lead to a policy which will be data driven and applied will be a balanced combination of prevention and harm reduction of risk factors and behaviors.”
Tanzania
The concept of reducing the harm from smoking has been integrated in legislation enacted as far back as two decades ago. Tanzania’s primary tobacco legislation, The Tobacco Products (Regulation) Act, introduced in 2003, includes the concept of harm reduction in its key objectives: “(d) ensuring that tobacco products are modified to reduce harm to such an extent as may be technologically and practically possible.”
United Kingdom
The U.K. Government released “The Tobacco Control Plan for England” in July 2017, emphasizing the role that e-cigarettes could play in reducing the harm caused by smoking:
“The evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco. The government will seek to support consumers in stopping smoking and adopting the use of less harmful nicotine products. […] In addition, there has been the development and very recent introduction of novel products that claim to reduce the harm of smoking. We welcome innovation that will reduce the harms caused by smoking and will evaluate whether products such as novel tobacco products have a role to play in reducing the risk of harm to smokers.”
“Our vision is to create a smokefree generation. We will have achieved this when smoking prevalence is at 5% or below. To deliver this, the government sets out the following national ambitions which will help focus tobacco control across the whole system:
[…]
4. Backing evidence-based innovations to support quitting
We are committed to evidence-based policy making, so we aim to:
• Help people to quit smoking by permitting innovative technologies that minimise the risk of harm.
• Maximise the availability of safer alternatives to smoking.”
Adult smokers have since been actively encouraged to try e-cigarettes as a way out of smoking, including through the Government’s annual stop smoking campaign “Stoptober” and a “swap to stop” scheme whereby one million smokers are provided with vape starter kits and counselling services.
Government agency assessments and research on smoke-free products
We welcome and encourage independent research on our products, methods, and results. Over the past several years, a growing number of organizations and institutions have initiated studies on smoke-free products, or the methods and results surrounding them. This includes numerous authoritative government agencies that have reviewed the available evidence on smoke-free products, or conducted research of their own, and have drawn conclusions showing the potential of smoke-free products as better alternatives to continued smoking. Some examples of such reports and studies by government agencies are provided below:
United Kingdom
E-cigarettes
PUBLIC HEALTH ENGLAND (PHE) AND OFFICE FOR HEALTH IMPROVEMENT AND DISPARITIES (OHID) – EVIDENCE REVIEWS (2014-2022)
Public Health England (PHE) was a governmental agency aimed at protecting and improving health while reducing health inequalities. PHE was disbanded in 2021 and its functions transferred to various agencies, with the tobacco-related functions moved to the Office for Health Improvement and Disparities (OHID).
Since 2014, PHE has conducted several scientific reviews on e-cigarettes, updating and expanding on the evidence of the implications of e-cigarettes for public health. Key conclusions across the PHE reports maintain that e-cigarettes are a less harmful alternative and can positively impact public health.
The 2022 update conducted by OHID was consistent with the findings of previous updates as well as the policy position of supporting smokers in switching to e-cigarettes while preventing nonsmokers from initiation. According to Nicotine vaping in England: 2022 evidence update main findings, the overall conclusions are:
- “In the short and medium term, vaping poses a small fraction of the risks of smoking.
- Vaping is not risk-free, particularly for people who have never smoked.
- Evidence is mostly limited to short and medium term effects and studies assessing longer term vaping (for more than 12 months) are necessary.
- More standardised and consistent methodologies in future studies would improve interpretation of the evidence.”
U.K. HOUSE OF COMMONS, SCIENCE & TECHNOLOGY COMMITTEE E-cigarettes: Seventh Report of Session 2017–19 (2018)
The Science & Technology Committee of the U.K. House of Commons published a report of its inquiry into e-cigarettes in August 2018 after reviewing over 100 pieces of written evidence, as well as oral evidence from 25 public health and industry experts. The Report makes conclusions based on the evidence presented to the Committee, as well as policy recommendations. The Committee concludes that “The best thing a smoker can do for their health is to quit smoking. However, the evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco,” according to the U.K. Department of Health (Report, page 8).
U.K. PUBLIC HEALTH ORGANIZATIONS Joint statement on e-cigarettes by Public Health England and other UK public health organisations (2016)
In 2016, Public Health England and 12 other public health organizations (including Action on Smoking and Health, Association of Directors of Public Health, British Lung Foundation, Cancer Research U.K., Faculty of Public Health, Fresh North East, Healthier Futures, Public Health Action, Royal College of Physicians, Royal Society for Public Health U.K., Centre for Tobacco and Alcohol Studies U.K. and Health Forum) issued a joint statement on e-cigarettes, mentioning that “We all agree that e-cigarettes are significantly less harmful than smoking. One in two lifelong smokers dies from their addiction. All the evidence suggests that the health risks posed by e-cigarettes are relatively small by comparison but we must continue to study the long-term effects.”
COMMITTEE ON TOXICITY OF CHEMICALS IN FOOD, CONSUMER PRODUCTS AND THE ENVIRONMENT (COT) Statement on the potential toxicological risks from electronic nicotine (and non-nicotine) delivery systems (E(N)NDS – e-cigarettes) (2020)
In September 2020, the U.K. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), on the request of the Department of Health and Social Care (DHSC) and Public Health England (PHE), assessed the potential risk to human health coming from electronic nicotine delivery systems (ENDS).
Overall, the COT concluded that:
- The use of E(N)NDS products, produced according to appropriate manufacturing standards and used as recommended, as a replacement for smoking cigarettes i.e., switching completely, is likely to lead to a reduction in harm to health.
- Comparing E(N)NDS use with combustible cigarette smoking, the Committee concluded that the relative risk of adverse health effects would be expected to be substantially lower from E(N)NDS. This risk reduction would occur if people who are already smoking combustible cigarettes switch to E(N)NDS, or if E(N)NDs are taken up instead of combustible cigarettes.
Heated tobacco products
Public Health England (PHE) (2018) released a report on the evidence behind cigarette alternatives, the fourth such review on e-cigarettes, and the first time it included heated tobacco products. PHE’s analysis of independent evidence on heated tobacco products, which was heavily focused on IQOS, considered eight independent studies in its review.
Amongst the report’s findings on heated tobacco products are a likely reduction in a user’s exposure to harmful chemicals compared to cigarettes, and that: “The available evidence suggests that heated tobacco products may be considerably less harmful than tobacco cigarettes and more harmful than [e-cigarettes].
The Office for Health Improvement and Disparities (OHID) (2022) partially covered heated tobacco products, reporting the Cochrane review’s findings on lower toxicant exposure for HTPs while calling for further research by stating:
- “The Cochrane review found moderate certainty evidence that smokers switching to HTPs have lower exposure to toxicants and carcinogens than smokers continuing to smoke.”
- “Monitoring of HTP uptake among young people and adults should continue.”
- “Research independent of manufacturers is needed into whether HTP help people stop smoking, their safety, and their impact on smoking rates.”
United States of America
Heated tobacco products
The U.S. Food & Drug Administration (U.S. FDA) (as of 2018), a federal agency of the U.S. Department of Health and Human Services, conducted an assessment of the IQOS aerosol and concluded: “The independent testing performed by STL confirmed the lower levels of selected HPHCs in the aerosol from the HeatSticks compared to mainstream cigarette smoke.” These conclusions were included in an FDA Briefing Document for the members of the Tobacco Products Scientific Advisory Committee (TPSAC).
Subsequently, on April 30, 2019, the U.S. Food and Drug Administration’s (FDA) Center of Tobacco Products (CTP) issued a market order letter for the Tobacco Heating Device (THD) and the Electrically Heated Tobacco Product (EHTP) to allow the introduction of the THD and EHTP into the U.S. market. The decision of the U.S. FDA followed “[…] a rigorous science-based review through the premarket tobacco product application (PMTA) pathway” based on which, “[…] the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health […]”
In their scientific review, the U.S. FDA “found that the aerosol produced by the IQOS Tobacco Heating System” [EHTP with THD] “contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke.
For example, the carbon monoxide exposure from IQOS aerosol is comparable to environmental exposure, and levels of acrolein and formaldehyde are 89 percent to 95 percent and 66 percent to 91 percent lower than from combustible cigarettes, respectively.”
Furthermore, the Agency concluded that “[…] IQOS delivers nicotine in levels close to combustible cigarettes suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively.”
Importantly, the U.S. FDA found that “Available data, while limited, also indicate that few non-tobacco users would be likely to choose to start using IQOS, including youth.”
Moreover, on July 7, 2020, the U.S. FDA issued a decision on the Modified Risk Tobacco Product (MRTP) applications for IQOS and the three HeatSticks variants submitted by PMI in December 2016.
Following a thorough review of the extensive scientific evidence package PMI submitted to the FDA to support the IQOS MRTP applications, the agency found that “the available scientific evidence demonstrates that the issuance of an exposure modification order for IQOS would be appropriate to promote the public health and is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.”
Important to note is that the regulatory framework in the U.S. allows the FDA to issue two types of modified risk orders: a “risk modification” order or an “exposure modification” order. PMI had requested both types of orders for the IQOS system. The FDA determined that “although the non‐clinical and clinical studies included in these applications were not sufficient to demonstrate that switching completely lowers the risk of disease compared to combusted cigarette smoking and failed to meet the threshold for issuance of a risk modification order at this time, the totality of evidence presented suggests that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies. This determination predominantly stems from the substantial reduction in HPHCs relative to combusted cigarette smoke. Although some chemicals of potential concern (not on FDA’s HPHC list) may be higher in IQOS users, the increase in these constituents does not impact the conclusion that the substantial reductions in HPHCs and findings from the toxicological evidence are reasonably likely to translate to lower risk of tobacco-related morbidity and mortality.”
This decision follows a stringent process which included:
- A review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications, which included a regular dialogue with PMI scientists to better understand the data submitted and to answer specific questions from the FDA
- Inspections from FDA officials at multiple PMI and study sites, including our factory and research facilities in Neuchâtel and Lausanne in 2017
- A comprehensive review of the independent data and publications around IQOS to date
- A comprehensive review of comments, data, and information submitted to FDA by interested persons (section 911(g)(4) of the FD&C Act)
The modified exposure order granted by the U.S. FDA for four years will authorize the communication of the following information to consumers with regards to the IQOS system in the United States:
Available evidence to date:
- The IQOS system heats tobacco but does not burn it.
- This significantly reduces the production of harmful and potentially harmful chemicals.
- Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
A similar modified exposure order was also granted to PMI for the IQOS 3 device and holder in March, 2022.
E-cigarettes
NATIONAL ACADEMIES OF SCIENCE, MEDICINE AND ENGINEERING (NASEM) Public Health Consequences of E-Cigarettes (2018)
The Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems of the National Academies of Science, Engineering and Medicine published a consensus study report titled “The Public Health Consequences of E-Cigarettes” in 2018 to conduct a review of scientific evidence that addresses competing views on the public health consequences of e-cigarettes.
The report recognizes the need to explore tobacco harm reduction policies by stating that “Despite these efforts and in spite of successes to reduce initiation and increase cessation, a substantial portion of Americans still become regular smokers. Some of these regular smokers are unwilling to quit, and even among those who want to quit, some have serious difficulty quitting. For these populations who continue to expose themselves and others to harm from combustible tobacco use, it is appropriate to consider strategies that minimize or reduce but not eliminate harm from smoking.” (18-1)
The report also asserts that encouraging the use of less risky products can only have public health benefits. “Nevertheless, if e-cigarettes confer lower health risks compared with combustible tobacco cigarettes, encouraging use of this reduced risk product rather than encouraging abstinence only could have public health benefits. As suggested by the Cochrane review’s conclusions, this approach might be especially salient for combustible tobacco cigarette smokers who are unable or unwilling to quit.” (18-2, pg 590).
FOOD & DRUG ADMINISTRATION (FDA) Authorization of e-cigarettes through PMTA Pathway (2021)
In October 2021, the FDA authorized the marketing of the first set of electronic nicotine delivery system (ENDS) products ever through the Premarket Tobacco Product Application (PMTA) pathway.
Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. Mitch Zeller, J.D., Director of the FDA’s Center for Tobacco Products at the time, said on the occasion “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals, […]”
The Netherlands
Heated tobacco products
National Institute for Public Health and the Environment (RIVM) (2018, 2020), an agency of the Dutch Ministry of Health, Welfare, and Sport, published its preliminary assessment of IQOS. The assessment, which is presented as a factsheet, is based on RIVM’s aerosol chemistry testing of IQOS, as well as published literature.
RIVM concluded: “The use of heatsticks with the IQOS is harmful to health, but probably less harmful than smoking tobacco cigarettes” based on their aerosol chemistry measurements, which are “of the same order of magnitude as in the data of Philip Morris.”
The more recent publication from RIVM (Slob et al., 2020), “A Method for Comparing the Impact on Carcinogenicity of Tobacco Products: A Case Study on Heated Tobacco Versus Cigarettes” compared the carcinogenicity of heated tobacco aerosol versus cigarette smoke. The methodology applied focused on the change in cumulative exposure (CCE) to compare two tobacco/nicotine products instead of performing risk assessments of individual compounds to allow a better understanding of if and how the health impact may differ between the products. The authors concluded that “[t]he CCE was estimated to be 10- to 25- fold lower when using HTPs instead of cigarettes. Such a change indicates a substantially smaller reduction in expected life span, based on available dose-response information in smokers. However, this is a preliminary conclusion, as only eight carcinogens were considered so far. Furthermore, an unfavorable health impact related to HTPs remains as compared to complete abstinence.”
The authors stated that even the lower bound of this uncertainty range would be associated with a substantial health impact in favor of the HTP. They added that assuming that the eight carcinogens used in this analysis are a representative sample of all carcinogens in smoke, then increasing the number of compounds in the analysis would make the CCE estimate more reliable, but would most likely not dramatically change it.
Overall, consuming a HTP such as the one studied instead of cigarettes will be associated with a substantial increase in life expectancy compared to continued smoking for the subgroup of smokers who would die from cancer. Moreover, they also suggest that the health impact will be greatest for habitual smokers who switch at a young age. It is also important to highlight that the authors make it clear that HTPs are not risk-free, and that there is a negative health impact expected to remain from consuming HTPs as compared to total abstinence from tobacco products.
E-cigarettes
The Dutch National Institute for Public Health and the Environment (RIVM) issued a report on Tobacco Harm Reduction and potentially less harmful tobacco products, including e-cigarettes and heat-not-burn products, amongst others in 2016.
The authors of the report take a favorable stance on tobacco harm reduction (THR) by referring to studies by THR-advocates and stating that “[harm reduction] offers alternatives to abstention for those people who cannot or are unwilling to quit but would like to lower the risks that cling to their behaviour.”
The summary of the section on e-cigarettes/ENDs states that: “The available data on the harmfulness of e-cigarettes show that e-cigarettes are a less harmful alternative for conventional cigarettes. It is not yet clear, however, whether e-cigarettes can play a role in smoking cessation and whether using e-cigarettes acts as a gateway to using conventional cigarettes.”
Germany
Heated tobacco products
The German Federal Institute for Risk assessment (BfR) (2018), a branch of the Federal Ministry for Food and Agriculture, is responsible for the assessment of issues related to consumer protection. The BfR analyzed IQOS aerosol and found reductions in selected toxicants (80-99 percent) compared to cigarette smoke, which was in line with PMI’s own research. The study states that while further studies are required to address the magnitude of exposure reduction, the “herein confirmed reductions of relevant toxicants by about 80–99% are substantial, leading to the relevant questions of putatively reduced health risks.”
In 2019, the BfR published an article titled “Heated Tobacco Products: A Review of Current Knowledge and Initial Assessments” confirming the findings of their previous study. “The German Federal Institute for Risk Assessment confirmed in its previous study substantially reduced toxicant levels for selected HTPs and provided an initial assessment in 2017. The profound reduction (>99%) of key carcinogens according to Fowles and Dybing, such as benzene and 1,3-butandiene, as well as substantial overall reductions of toxicants is expected to affect health risks, if people abstain completely from other tobacco products. Nicotine levels are still in range of conventional cigarettes, limiting the risk to switch back to conventional smoking tobacco.”
Nicotine pouches
The BfR also published its “Health Assessment of Nicotine Pouches” in October, 2022. This document marks the end of a series of preliminary assessments of the BfR and adds its own experimental research and additional studies to the already known set of literature research and risk calculations. The experimental research was conducted in cooperation with the Ludwig Maximilian University of Munich and included a comparison of nicotine pouches with cigarettes. The BfR report states: “switching from cigarettes to nicotine pouches could represent a reduction in health risks for a person who smokes. However, measures should be taken to avoid that use of nicotine pouches leads to a higher nicotine intake compared with other products on the market.
With this assessment, the BfR has retained its position on nicotine pouches, now substantiated by the results of its own experimental and clinical research. It reiterated the potential of nicotine pouches in the light of harm reduction, providing an abundance of evidence balancing the risks of these products.
Korea
Heated tobacco products
The Korean Ministry of Food and Drug safety (MFDS) (2018) issued a statement on products that heat rather than burn tobacco, based on measurements performed in their own laboratories of three HNB products, including IQOS.
They measured the nine Harmful and Potentially Harmful Constituents (HPHCs) defined by the WHO as a priority list for mandatory reduction, as well as nicotine and “tar.”
MFDS results confirm significant reductions of HPHCs in HNB products compared to cigarettes—but omit to discuss them. In their discussion, MFDS mention that HNB products also contain carcinogens, such as benzopyrene and benzene. What they fail to mention is that the levels measured are more than ten times lower compared to the levels present in cigarette smoke. In fact, their own data shows that these two carcinogens are reduced by more than 95 percent (for benzopyrene) and more than 99 percent (for benzene) when comparing the levels of HNB products to the top-five most sold cigarette brands in Korea. When considering the nine measured HPHCs, the average reduction of HNB products compared to Korean cigarettes (top-five most sold brands) is more than 90 percent.
PMI’s public comment on the MFDS statement is available on the PMI Science website.
China
Heated tobacco products
The China National Tobacco Quality Supervision and Test Centre (“CNTQSTC”) (2018), a member of the WHO Tobacco Laboratory Network (TobLabNet), published on January 8, 2018 an independent study in Nicotine & Tobacco Research. The study compares the HPHCs present in the IQOS aerosol and the 3R4F reference cigarette smoke.
The peer-reviewed publication by Li et al (2018), includes percentage reduction results of carbon monoxide and 25 Harmful and Potentially Harmful Constituents (HPHCs) in IQOS aerosol versus 3R4F reference cigarette smoke using the ISO and Health Canada intense testing regime. The authors stated that “the majority of mainstream constituents of THS 2.2 were reduced compared to 3R4F [reference cigarette].” Specifically, they found that compared to the 3R4F reference cigarette, IQOS produced “more than 90% [lower levels of] HPHCs, except for carbonyls, ammonia, and NAB, which were about 50–80% lower.” The authors cautioned “that reduction of harmful constituent emissions cannot be interpreted as equivalent to a proportionate harm/risk reduction for smokers.”
Japan
Heated tobacco products
The Department of Environmental Health, National Institute of Public Health in Japan (2017), one of the WHO Tobacco Laboratory Network (TobLabNet) laboratories, analyzed nicotine, tar, carbon monoxide (CO) and tobacco-specific nitrosamines (TSNAs) in the mainstream aerosol and tobacco fillers of IQOS regular and menthol consumables, and compared their concentrations with those from reference cigarettes (3R4F and 1R5F) using WHO TobLabNet methods.
The authors conclude that “In this study we could provide important information showing that the concentration levels of hazardous compounds in the mainstream smoke of IQOS are much lower than those in conventional combustion cigarettes. Although it is low concentration, toxic compounds are definitely included in the mainstream smoke of IQOS."
Canada
Health Canada published a discussion paper to conduct the first review of the Tobacco and Vaping Products Act, 2018, examining early evidence from the first three years of the law coming into force, particularly with respect to vaping.
Ukraine
Heated Tobacco Products
One of Ukraine’s leading national scientific centers, the M.D. Strazhesko Institute of Cardiology provides scientific advice for the Ukrainian government. In 2017, the institute conducted a six-month clinical study which was published in a prominent national medical periodical, “Ukrainian Health.” The study was focused on IQOS and the risk of cardiovascular diseases based on endothelial function and its determining factors. The authors highlighted that “The obtained results show significantly less harmful influence of ENDS/IQOS on cardiovascular function if compared to tobacco smoke” and that it confirms “... the possibility to consider them as harm reduction products for smokers who do not want or are not ready to quit smoking completely.”
