Background Philip Morris International (PMI) continually expands and diversifies their nicotine product portfolio, which includes IQOS, a heated tobacco product. In December 2016, PMI filed a modified risk tobacco product (MRTP) application with the US Food and Drug Administration (FDA), seeking authorisation to market IQOS in USA with three claims of reduced harm: ‘switching completely from conventional cigarettes to the IQOS system…’ (1) ‘can reduce the risks of tobacco-related diseases;’ (2) ‘significantly reduce[s] your body’s exposure to harmful or potentially harmful chemicals;’ and (3) ‘presents less risk of harm than continuing to smoke cigarettes.’ Consumers may misunderstand what is meant by ‘switching completely'.
Methods We critically reviewed study reports submitted to FDA by PMI in support of proposed marketing claims in its MRTP application for IQOS and focused on the statement that switching completely to IQOS reduces risk.
Results We found deficiencies with evidence provided by PMI supporting their assertions that: current smokers will understand what is meant by the phrase ‘switching completely'; the proposed claims will not decrease smokers’ intentions to quit; and IQOS users will in fact ‘switch completely’ from smoking cigarettes to using IQOS. The studies and measurement instruments employed by PMI suffer from design flaws and their reporting of associated findings is misleading.
Conclusion Consumers will not understand the condition of the claims—that they must quit using cigarettes completely to achieve the inferred health benefits of IQOS. Rather, they are likely to misunderstand the unsupported claims of reduced risks to mean IQOS are harm-free.
- advertising and promotion
- non-cigarette tobacco products
- packaging and labelling
- tobacco industry
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Contributors All authors contributed to the literature review, analyses and writing of the paper.
Funding This work was supported by the US National Cancer Institute and Food and Drug Administration Center for Tobacco Products (P50 CA180890, R00 CA187460) and the National Institute of Drug Abuse and Food and Drug Administration Center for Tobacco Products (P50 DA036128).
Disclaimer The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health or the FDA. 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; or decision to submit the manuscript for publication.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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