Introduction Heated tobacco products (HTPs) are being marketed in several countries around the world with claims that they are less harmful than combusted cigarettes, based on assertions that they expose users to lower levels of toxicants. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration (FDA) in 2016 seeking authorisation to market its HTPs, IQOS, with reduced risk and reduced exposure claims.
Methods We examined the PMI’s Perception and Behavior Assessment Studies evaluating perceptions of reduced risk claims that were submitted to the FDA and made publicly available.
Results Qualitative and quantitative studies conducted by PMI demonstrate that adult consumers in the USA perceive reduced exposure claims as reduced risk claims.
Conclusion The data in the PMI modified risk tobacco product IQOS application do not support reduced risk claims and the reduced exposure claims are perceived as reduced risk claims, which is explicitly prohibited by the FDA. Allowing PMI to promote IQOS as reduced exposure would amount to a legally sanctioned repeat of the ‘light’ and ‘mild’ fraud which, for conventional cigarettes, is prohibited by the US law and the WHO Framework Convention on Tobacco Control.
- advertising and promotion
- non-cigarette tobacco poroducts
- packaging and labelling
- tobacco industry
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Contributors All authors conceptualised the study, contributed to the writing and revision and approved the final version of the manuscript. LP and LKL analysed the data.
Funding This work was supported by the US National Cancer Institute and Food and Drug Administration (FDA) Center for Tobacco Products (P50 CA180890, R00 CA187460) and the National Institute of Drug Abuse and FDA Center for Tobacco Products (P50 DA036128). The content is solely the responsibility of the authors 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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