Growing scientific and regulatory consensus on tobacco harm reduction

“The Smokefree Environments and Regulated Products (Vaping) Amendment Act 2020” (“2020 Act”) regulated vaping (e-cigarettes and smokeless/heated tobacco products). The 2020 Act recognized that vaping products are less harmful than smoked tobacco. One of the 2020 Act’s purposes was to “support smokers to switch to significantly less harmful products,” although the 2022 Amendment (defined below) has modified the purpose towards youth access prevention. 

As a result, vaping products are exempted from some of the restrictions applied to smoked tobacco products, to allow more communication about “significantly less harmful products” for adult smokers.

Vaping regulations to implement the 2020 Act were introduced in 2021 and reinforce a risk-proportionate approach by, for example, removing the requirement that smokeless tobacco products be sold in plain packaging and by adapting different health warnings for smokeless tobacco products and vaping substances than for smoked tobacco products.

In late 2021, the Government released its Smokefree Action Plan, proposing measures to reduce the appeal and availability of smoked tobacco products, such as reducing the number of retail outlets, lowering nicotine content, and introducing a smokefree generation policy, amongst others, leading to “The Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act 2022” (“2022 Amendment”). It was passed in December 2022, and aims to gradually phase out smoked tobacco while leaving out e-cigarettes and smokeless/heated tobacco products from this phase-out. The 2022 Amendment significantly revoked an earlier regulation and now allows a smokeless tobacco product to show on packaging it has emissions with fewer harmful constituents than tobacco smoke. Regulations to implement the 2022 Amendment are expected later in 2023.

On the occasion of proposing phase-out measures in 2021, the then-Prime Minister made it clear that the phase-out of smoked tobacco was only possible due to the availability of less harmful alternatives: 

“We already see vaping being used by people as a tool to stop smoking and that actually enables us to push ahead with further activity to reduce down smoking because there is an alternative that works very successfully for people in order to stop smoking (...) We know that vaping is making a difference for those now in order to stop smoking and so it is an important tool.” 

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.” ⁶ 

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.” 

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% to 95% and 66% to 91% 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 Neuchatel 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, […]”

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, the authors 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.”

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% (for benzopyrene) and more than 99% (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%.

PMI’s public comment on the MFDS statement is available on the PMI Science website.

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."