ArticleTobacco control2020
Analysis of FDA's IQOS marketing authorisation and its policy impacts.
Article in Tobacco control, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed.
- Effect of a hypothetical modified risk tobacco product claim on heated tobacco product use intention and perceptions in young adults.Tobacco control · 2023Trial
- Nationwide trends in cigarette, heated tobacco product, e-cigarette, and multiple-product use in Japan 2017-2025.PCN reports : psychiatry and clinical neurosciences · 2026Article
- Qualitative Examination of US and Israeli Adults' Perceptions of IQOS Advertising Messages: Modified Exposure and Risk Statements, US FDA Endorsement, and Health Warnings.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025Article
- IQOS and cigarette advertising across regulatory periods and population groups in Israel: a longitudinal analysis.Tobacco control · 2024Article
- Vuse Solo e-cigarettes do not provide net benefits to public health: a scientific analysis of FDA's marketing authorisation.Tobacco control · 2024Review
- How might FDA fix this e-cigarette PMTA mess? Commentary on Glantz and Lempert and MeshnickTobacco control · 2024Article
- The effect of heated tobacco products on metabolic syndrome: A cohort study.Tobacco induced diseases · 2024Article
- How Media Stories in Low- and Middle-Income Countries Discussed the U.S. Food and Drug Administration's Modified Risk Tobacco Product Order for IQOS.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2023Article
- Effects of heated tobacco products and conventional cigarettes on dental implant wound healing: experimental research.Annals of medicine and surgery (2012) · 2023Article
- FDA's reduced exposure marketing order for IQOS: why it is not a reliable global model.Tobacco control · 2022Article
- Turkish Thoracic Society's Statement Report on Electronic Cigarettes and Heated Tobacco Products.Turkish thoracic journal · 2022Article
- Perceived harm of heated tobacco products, e-cigarettes, and nicotine replacement therapy compared with conventional cigarettes among ever and current heated tobacco users.Addictive behaviors reports · 2022Article
- Heated tobacco product use, its correlates, and reasons for use among Mexican smokers.Drug and alcohol dependence · 2022Article
- Cytotoxic, genotoxic, and toxicogenomic effects of heated tobacco products and cigarette smoke in human primary keratinocytes.Tobacco induced diseases · 2022Article
- United States Food and Drug Administration's authorization of reduced exposure claims for IQOSRevista panamericana de salud publica = Pan American journal of public health · 2022Article
- Successful countering of tobacco industry efforts to overturn Thailand's ENDS ban.Tobacco control · 2021Article
- Heated Tobacco Product Awareness, Use, and Perceptions in a Sample of Young Adults in the United States.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2021Article
- How to combat efforts to overturn bans on electronic nicotine delivery systems: lessons from tobacco industry efforts during the 1980s to open closed cigarette markets in Thailand.BMJ global health · 2021Review
- Unboxed: US Young Adult Tobacco Users' Responses to a New Heated Tobacco Product.International journal of environmental research and public health · 2020Article
- Cigarette or E-Cigarette Use as Strong Risk Factors for Heated Tobacco Product Use among Korean Adolescents.International journal of environmental research and public health · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
backgroundPhilip Morris Products SA (PMPSA) submitted a premarket tobacco application (PMTA) to US Food and Drug Administration (FDA) seeking an order permitting it to market IQOS in the USA. US law requires FDA to deny marketing authorisation if applicants fail to demonstrate that their product is 'appropriate for the protection of the public health'. FDA issued a marketing order for IQOS in April 2019, which Philip Morris is using to promote IQOS outside the USA.
methodsWe analysed FDA's Technical Project Lead Review and marketing order for IQOS, relevant law and guidance on PMTAs and independent research on the health impacts of IQOS.
resultsFDA found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic potential, some at higher levels than conventional cigarettes. PMPSA did not appropriately consider the health impacts of dual use, the product's attractiveness to youth or data showing that consumers do not accurately perceive the addiction risks of IQOS. Despite FDA's own scientists' recommendations and independent research showing that IQOS presents serious risks to users including cytotoxic, genotoxic, hepatotoxic, cardiovascular and pulmonary risks, FDA concluded that IQOS is 'appropriate for the protection of the public health'.
conclusionFDA's decision allowing IQOS to be marketed in the USA disregarded valid scientific evidence and misapplied the public health standard mandated by law. This decision may have important health impacts, influence marketing IQOS outside the USA and erode public confidence in FDA's future PMTA decisions.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.