Growing scientific and regulatory consensus on tobacco harm reduction

Overall, PMI secured thirteen (13) out of sixteen (16) modified risk tobacco product authorizations ever granted by the FDA - more than any other company. This is undoubtedly setting the standard for science-driven innovation.

The U.S. FDA’s Center for Tobacco Products, also referred to as CTP, has been established to make tobacco-related death and disease part of the nation’s past by ensuring a healthier future for those living in the United States. Building upon the strong foundation that was established and has been cultivated since the center’s inception in 2009, CTP protects the public health of the U.S. population from tobacco-related death and disease by comprehensively: 

• Regulating the manufacture, distribution, and marketing of tobacco products
• Educating the public, especially youth, about the dangers of using tobacco products
• Promoting and supporting strategies that ensure a healthier life for everyone

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.  

Additionally, with the adoption of regulatory framework for nicotine pouches in July 2025 the Greek government has introduced age, product and advertising restrictions, as well as a premarket notification requirement, while clearly differentiation rules applying to nicotine pouches from those providing stricter limitations for cigarettes.

In the explanatory report to the Tobacco Law, the Swiss Government stated that “… the recognition of these alternative products and the elaboration of specific provisions can encourage smokers of conventional cigarettes to switch to a less harmful product.”

Portugal has formalized the regulation of nicotine pouches by establishing a new excise tax category for these products in December 2025. It has introduced a dedicated classification for nicotine pouches under fiscal law and applied a nicotine limit of 12mg/pouch. This indicates the country’s intention to formally incorporate safer nicotine alternatives into its policy framework and the need for clear taxation and proportionate regulation of nicotine pouches, aiming to support consumer protection and harm reduction objectives.

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, […]”

On July 17, 2025, the FDA reversed its previous position on electronic nicotine delivery systems (ENDS), when analyzing a PMTA, by authorizing the sale and concluding that the products are “appropriate for the protection of public health” (APPH). This marks a significant regulatory milestone. The authorization was obtained by JUUL Labs Inc. for its tobacco- and menthol flavored pod-based ENDS products and the decision follows a scientific review of JUUL's PMTAs.

Nicotine pouches

FOOD & DRUG ADMINISTRATION (FDA) Authorization of ZYN nicotine pouches through PMTA pathway (2025)

In January 2025, the FDA authorized the marketing of 20 oral nicotine pouch products, commercialized as ZYN by PMI’s subsidiary Swedish Match, through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized oral nicotine pouches in the U.S. market.

The FDA’s press release stated: “Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.”

The press release also stated: “Additionally, the FDA found that the applicant showed these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth. As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years.”

PMI also submitted MRTPAs for ZYN products and requested authorization of a modified risk claim. In February 2025, the FDA formally accepted our MRTPAs and in June 2025, issued a filing letter for 20 ZYN nicotine pouch products. This action initiated a scientific review of our MRTPAs which requested the following modified risk claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The FDA referred these applications to the Tobacco Products Scientific Advisory Committee (TPSAC), which met on January 22, 2026. The role of TPSAC is to review and evaluate scientific issues, including safety, dependence, and health issues relating to tobacco products and provide advice, information, and recommendations to the FDA.

During the full-day meeting on January 22, that was part of the FDA’s scientific review of our application to use the reduced risk claim for ZYN products, the FDA stated in their presentation to the committee: "The evidence suggests the proposed modified risk claim is scientifically accurate." Additionally, the FDA noted: “Youth nicotine pouch use prevalence is currently relatively low” and “among young adults, viewing the proposed claim did not increase intentions to use ZYN.” 

We remain optimistic about the outcome of our MRTPA application for nicotine pouch products.

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.

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.”

In a recent consultation, Health Canada reported that many Canadians attempting to quit smoking are turning to nicotine vaping and say it has helped them. The department also notes that current evidence, though evolving, suggests “vaping nicotine (e-cigarettes) can help adults quit smoking”, referencing independent reviews to support this conclusion. Recent national data show that 21% of Canadians who quit smoking in 2024 used e-cigarettes during their quit attempt, underscoring the growing relevance of this method as a cessation tool. 

Health Canada’s public guidance reinforces this harm reduction message. It advises that for adults who continue to smoke despite trying approved cessation methods, switching completely to vaping nicotine is less harmful than continuing to smoke, while stressing that youth and nonsmokers should not vape.

Overall, these updates reflect Health Canada’s increasing recognition of real-world consumer behavior and its emerging openness to reduced risk alternatives.