R Street Testimony in Support of the Renewal of the MRTPA for IQOS
October 7, 2025
Dr. Bret Koplow
Acting Director
Center for Tobacco Products (CTP)
United States Food and Drug Administration
Rockville, MD 20852
Re: Docket No. FDA-2025-N-2030
Dear Dr. Koplow and members of the Tobacco Products Scientific Advisory Committee,
The R Street Institute (R Street) respectfully submits the following comments in response to the public meeting on the modified risk tobacco product (MRTP) application for IQOS products submitted by Philip Morris Products S.A. R Street is a nonprofit, nonpartisan public policy organization focused on advancing free markets and limited, effective government in various areas, including Integrated Harm Reduction. Our work is based on the belief that health policy rooted in harm reduction can significantly reduce the adverse outcomes of harmful behaviors and alleviate the burdens of healthcare costs. Decades of research show that abstinence-only methods are ineffective at a population level for risky behaviors. Policies that criminalize behaviors like smoking lead to unintended negative consequences.
We are writing this letter to express our strong support for the renewal of the MRTPA for the IQOS product line, including the Marlboro Amber HeatSticks, Marlboro Green Menthol HeatSticks, Marlboro Blue Menthol HeatSticks, IQOS 2.4 System Holder and Charger, and IQOS 3.0 System Holder and Charger. As advocates for public health and evidence-based tobacco regulation, we believe that renewing this MRTPA aligns with the principles of tobacco harm reduction and the continuum of risk framework, which are essential for reducing tobacco-related diseases in the United States. The IQOS system, a heat-not-burn tobacco product developed by Philip Morris International, represents a scientifically supported alternative for adult smokers who are unable or unwilling to quit nicotine use entirely. By heating tobacco rather than combusting it, IQOS significantly reduces exposure to harmful and potentially harmful chemicals compared to traditional combustible cigarettes, thereby offering a pathway to mitigate the health risks associated with smoking.
Tobacco use remains one of the leading preventable causes of death in the United States, with combustible cigarettes accounting for the vast majority of tobacco-related morbidity and mortality. According to the U.S. Surgeon General, cigarette smoking causes over 480,000 deaths annually, primarily due to exposure to toxicants produced by combustion, such as tar, carbon monoxide, and numerous carcinogens. In this context, the concept of tobacco harm reduction (providing less harmful alternatives to smokers) has emerged as a pragmatic public health strategy. Harm reduction recognizes that while complete abstinence from nicotine is ideal, many smokers face significant barriers to quitting. Instead of insisting on an all-or-nothing approach, harm reduction encourages transitioning users to products lower on the continuum of risk, where combusted tobacco products like cigarettes occupy the highest risk position, and non-combusted alternatives, including heated tobacco products (HTPs) like IQOS, offer substantially reduced harm.[1]
The continuum of risk is a well-established framework in tobacco control, endorsed by scientific consensus and regulatory bodies. It posits that tobacco and nicotine products exist on a spectrum of harm, with the level of risk determined primarily by the delivery method and the presence of combustion. Combusted products, such as cigarettes, are at the most harmful end because burning tobacco at high temperatures (over 600°C) generates thousands of toxic chemicals, including over 70 known carcinogens. In contrast, non-combusted products, like smokeless tobacco or medicinal nicotine, are at the lower end. Heated tobacco products, which heat tobacco to around 350°C without burning it, fall in between, producing an aerosol with significantly fewer and lower levels of harmful constituents.[2] This framework is not merely theoretical; it is grounded in extensive research demonstrating that switching to lower-risk products can reduce individual and population-level health risks. For instance, the National Academies of Sciences, Engineering, and Medicine have acknowledged that e-cigarettes, another non-combusted product, likely expose users to fewer toxicants than combustible cigarettes, supporting the harm reduction potential of such alternatives.[3] Extending this logic to HTPs like IQOS is consistent with promoting public health by encouraging smokers to migrate down the risk continuum.
Scientific evidence specifically on IQOS underscores its position on the lower end of the risk continuum compared to cigarettes. Studies have shown that IQOS produces vapor containing nearly 90% fewer toxic substances than cigarette smoke, including reduced levels of volatile organic compounds, polycyclic aromatic hydrocarbons, and other harmful chemicals.[4] For example, nicotine levels in IQOS aerosol are comparable to those in cigarettes, ensuring satisfaction for smokers, but concentrations of nitrosamines and carbon monoxide are dramatically lower—approximately one-fifth and 1% of cigarette levels, respectively. This reduction in toxicants translates to lower environmental and second-hand exposure risks, as IQOS emissions contain fewer submicron particles that linger in the air compared to cigarette smoke. Such findings align with the harm reduction paradigm, where the goal is to minimize exposure to combustion byproducts without necessarily eliminating nicotine use.
Further supporting this, a scoping review of IQOS toxicity and health impacts compiled data from various studies, revealing that while results vary by funding source, manufacturer-conducted research consistently demonstrates reduced toxicity and carcinogenicity in animal models exposed to IQOS aerosol versus cigarette smoke.[5] In chronic exposure experiments using mice, IQOS showed lower impacts on lung inflammation, emphysematous changes, and cardiovascular systems after extended periods. Clinical studies in the review also indicated reductions in biomarkers of exposure to harmful and potentially harmful constituents (HPHCs) by 47% to 96% among smokers who switched to IQOS, alongside improvements in health effect biomarkers such as high-density lipoprotein cholesterol and lung function. Even independent studies, while sometimes reporting mixed results, have noted that IQOS induces less cytotoxicity in lung epithelial cells (90–95% reduction) and impairs endothelial function to a lesser degree than cigarettes. These outcomes reinforce the continuum of risk, positioning IQOS as a less harmful option that can facilitate harm reduction for persistent smokers.
Biomarkers of potential harm (BoPH) provide objective measures of the health benefits associated with switching to IQOS. A systematic review and meta-analysis of HTPs, including IQOS, examined effects on BoPH such as those related to cardiovascular function, oxidative stress, and inflammation.[6] Under controlled conditions, HTPs demonstrated largely beneficial effects on biomarkers of endothelial dysfunction, oxidative stress, and platelet function compared to cigarettes. In ambulatory settings, similar benefits were observed for respiratory function and metabolic syndrome markers, with mixed but predominantly positive outcomes for inflammation. Although the review highlights the need for longer-term independent studies, the existing data suggest that short-term use of HTPs like IQOS can mitigate some of the harms inflicted by continued cigarette smoking. This evidence supports renewing the MRTPA, as it indicates that IQOS can play a role in reducing the overall risk profile for adult smokers within the harm reduction framework.
Pulmonary health, a primary concern in tobacco use, also benefits from switching to IQOS. Research investigating the impact of transitioning from cigarettes to HTPs on lung infection outcomes found that such a switch results in modest reductions in endothelial damage and improved bacterial clearance in the lungs compared to continued cigarette exposure.[7] In mouse models pre-exposed to cigarette smoke and then switched to IQOS, plasma markers of lung damage decreased, and inflammatory responses were less severe during acute challenges. While complete cessation yielded the best results, the study underscores that switching to IQOS offers partial protection against pulmonary complications, aligning with the continuum of risk where partial harm reduction is preferable to none. This is particularly relevant for smokers at high risk for respiratory diseases, as IQOS reduces exposure to irritants that exacerbate conditions like chronic obstructive pulmonary disease (COPD).
Real-world evidence from natural experiments further validates the harm reduction potential of IQOS. In a study examining tobacco behaviors before and after IQOS availability in the U.S. market, adult users reported a significant decrease in cigarette consumption upon adopting IQOS, with the proportion of cigarette users dropping from 89.9% to 63.0% and weekly cigarette intake falling from 106.3 to 39.0.[8] Notably, following market removal, cigarette use rebounded, highlighting IQOS’s role in sustaining reduced smoking. Regression analyses showed that IQOS use was associated with 86% higher odds of quitting cigarettes entirely. This demonstrates how IQOS facilitates movement down the risk continuum, reducing combustible tobacco use and associated harms.
The FDA has already recognized these benefits through its authorization of reduced-exposure claims for IQOS. In 2022, the agency granted a modified risk order allowing marketing claims that switching completely to IQOS significantly reduces exposure to harmful chemicals, based on evidence that the system heats tobacco without burning it, thereby lowering HPHC production.[9] This decision was informed by scientific studies showing substantial reductions in bodily exposure to toxicants. Renewing the MRTPA would build on this precedent, ensuring continued access to a product that supports harm reduction while maintaining regulatory oversight to prevent youth initiation and monitor long-term effects.
Critics may argue that HTPs like IQOS could renormalize tobacco use or appeal to non-smokers, but evidence suggests otherwise. Risk perception studies indicate that users view IQOS as less harmful than cigarettes but not risk-free, encouraging switches among smokers rather than new uptake.[10] Moreover, the FDA’s continuum of risk framework emphasizes regulating products based on their relative harm, with safeguards like age restrictions and marketing limitations to protect vulnerable populations. By renewing the MRTPA, the agency can enforce these measures, ensuring IQOS contributes positively to public health.
In conclusion, renewing the MRTPA for the IQOS product line is a science-driven decision that advances tobacco harm reduction and respects the continuum of risk. The evidence from peer-reviewed literature and FDA evaluations demonstrates that IQOS offers adult smokers a less harmful alternative, reducing exposure to toxicants and potentially lowering disease risks. Denying renewal could drive users back to more harmful combustible cigarettes, undermining public health goals. We urge the FDA to prioritize this renewal to save lives and reduce the societal burden of tobacco use.
Thank you for considering this letter as part of the public comment process.
Respectfully submitted,
Jeffrey S. Smith, Ph.D.
Resident Senior Fellow
R Street Institute
(971) 678-5022
jsmith@rstreet.org
[1] Hatsukami, D. K., & Carroll, D. M. (2020). Tobacco harm reduction: Past history, current controversies and a proposed approach for the future. Preventive Medicine, 140, 106099. https://www.sciencedirect.com/science/article/pii/S0091743520301237
[2] U.S. Food and Drug Administration. (2025). The relative risks of tobacco products. Retrieved from https://www.fda.gov/tobacco-products/health-effects-tobacco-use/relative-risks-tobacco-products
[3] National Academies of Sciences, Engineering, and Medicine. (2018). Public health consequences of e-cigarettes. The National Academies Press. https://nap.nationalacademies.org/catalog/24952/public-health-consequences-of-e-cigarettes
[4] Başaran, R., Güven, N. M., & Eke, B. C. (2019). An overview of iQOS® as a new heat-not-burn tobacco product and its potential effects on human health and the environment. Turkish Journal of Pharmaceutical Sciences, 16(3), 371–374. https://pmc.ncbi.nlm.nih.gov/articles/PMC7227951/
[5] Ghazi, S., Song, M.-A., & El-Hellani, A. (2024). A scoping review of the toxicity and health impact of IQOS. Tobacco Induced Diseases, 22, Article 188867. https://pmc.ncbi.nlm.nih.gov/articles/PMC11145630/
[6] Braznell, S., Dance, S., Hartmann-Boyce, J., & Gilmore, A. (2025). Impact of heated tobacco products on biomarkers of potential harm and adverse events: A systematic review and meta-analysis. Tobacco Control. Advance online publication. https://tobaccocontrol.bmj.com/content/early/2025/04/16/tc-2024-059000.abstract
[7] Bhat, T. A., Kalathil, S. G., Leigh, N. J., et al. (2024). Can switching from cigarettes to heated tobacco products reduce consequences of pulmonary infection? Respiratory Research, 25, 381. https://link.springer.com/article/10.1186/s12931-024-02992-y
[8] Noggle, B., Ball, K. M., & Vansickel, A. R. (2024). A reduced exposure heated tobacco product was introduced then abruptly taken off United States shelves: Results from a tobacco harm reduction natural experiment. Harm Reduction Journal, 21, 84. https://link.springer.com/article/10.1186/s12954-024-01000-2
[9] U.S. Food and Drug Administration. (2022). FDA authorizes reduced exposure claim for IQOS 3 system holder and charger. Retrieved from https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-reduced-exposure-claim-iqos-3-system-holder-and-charger
[10] Hatsukami, D. K., & Carroll, D. M. (2020). Tobacco harm reduction: Past history, current controversies and a proposed approach for the future. Preventive Medicine, 140, 106099. https://www.sciencedirect.com/science/article/pii/S0091743520301237