Background New electronic heated tobacco products are being introduced in the global market and are gaining popularity. In 2016, Philip Morris International, Inc. (PMI) submitted a modified risk tobacco product (MRTP) application to the Food and Drug Administration (FDA) to market IQOS in the USA with claims of reduced exposure and reduced risk.
Methods We examined PMI’s MRTP application, specifically sections on aerosol chemistry and human exposure assessment, to assess the validity of PMI’s claims of reduced exposure and risk.
Findings PMI reported levels for only 40 of 93 harmful and potentially harmful constituents (HPHCs) on FDA’s HPHC list in IQOS mainstream aerosol. All substances in PMI’s list of 58 constituents (PMI-58) were lower in IQOS emissions compared with mainstream smoke of 3R4F reference cigarettes. However, levels of 56 other constituents, which are not included in the PMI-58 list or FDA’s list of HPHCs, were higher in IQOS emissions; 22 were >200% higher and seven were >1000% higher than in 3R4F reference cigarette smoke. PMI’s studies also show significantly lower systemic exposure to some HPHCs from use of IQOS compared with smoking combustible cigarettes.
Conclusion PMI’s data appear to support PMI’s claim that IQOS reduces exposure to HPHCs. However, PMI’s data also show significantly higher levels of several substances that are not recognised as HPHCs by the FDA in IQOS emissions compared with combustible cigarette smoke. The impact of these substances on the overall toxicity or harm of IQOS is not known.
- electronic nicotine delivery devices
- harm reduction
- non-cigarette tobacco products
- smoking caused disease
- tobacco industry
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Contributors All authors were involved in interpretation of data and writing and revising the manuscript. All authors approve this version of the manuscript for publication.
Funding This work was supported by the National Cancer Institute and Food and Drug Administration Center for Tobacco Products (P50 CA180890), National Institute on Drug Abuse (R01 DA039264 and P30 DA012393) and the Tobacco Related Disease Research Program (TRDRP) (25IR-0028).
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the Food and Drug Administration or TRDRP. The funding agencies played no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript.
Competing interests NLB has served on smoking cessation advisory boards for Pfizer and has been an occasional consultant to McNeil and Achieve Life Sciences and has served as a paid expert witness in litigation against tobacco companies.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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