Author:
St.Helen Gideon,Jacob III Peyton,Nardone Natalie,Benowitz Neal L
Abstract
BackgroundNew 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.MethodsWe 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.FindingsPMI 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.ConclusionPMI’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.
Funder
National Institute on Drug Abuse
National Cancer Institute and Food and Drug Administration Center for Tobacco Products
Tobacco Related Disease Research Program
Subject
Public Health, Environmental and Occupational Health,Health(social science)
Reference45 articles.
1. E-Cigarettes
2. Smith C , Swauger J . Lung cancer risk and cigarettes which primarily heat but do not burn tobacco. 2000. Truth Tobacco Industry Documents. https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/#id=lsbj0091 (accessed 16 Feb 2018).
3. McGill D . Smokeless’ cigarette’s hapless start. 1988 http://www.journalnow.com/business/business_news/local/reynolds-ends-revo-test-market-in-wisconsin/article_e23495d0-353e-11e5-98d3-cbaf921dc91c.html (accessed 16 Feb 2018).
4. US patents shed light on eclipse and future cigarettes;Pauly;Tob Control,1995
5. Clinical laboratory evaluation of potential reduced exposure products for smokers
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