Assessment of industry data on pulmonary and immunosuppressive effects of IQOS

Abstract

IntroductionHeated tobacco products are being touted as novel reduced-harm tobacco products by tobacco companies. In the USA, Philip Morris International submitted a modified risk tobacco product (MRTP) application to the US Food and Drug Administration in 2016 in which it purports that its heated tobacco product, I-Quit-Ordinary-Smoking (IQOS), is associated with reduced harm compared with conventional cigarettes.MethodsWe reviewed Philip Morris International’s MRTP application to assess the pulmonary and immune toxicities associated with IQOS use in both animal and human studies.ResultsAmong rats exposed to IQOS, there was evidence of pulmonary inflammation and immunomodulation. In human users, there was no evidence of improvement in pulmonary inflammation or pulmonary function in cigarette smokers who were switched to IQOS.ConclusionIQOS is associated with significant pulmonary and immunomodulatory toxicities with no detectable differences between conventional cigarette smokers and those who were switched to IQOS in Philip Morris International’s studies. Philip Morris International also failed to consider how dual use and secondhand aerosol exposure may further impact, and likely increase, the harms associated with these products.

Light and mild redux: heated tobacco products’ reduced exposure claims are likely to be misunderstood as reduced risk claims

“…Several of the other papers in this supplement indicate that IQOS is not significantly less harmful than combusted cigarettes 2 – 4 46 47 and that while IQOS had lower levels of pulmonary cytotoxicity 48 and carcinogens 49 than combusted cigarettes, they were higher than those of e-cigarettes. Therefore, the limited evidence on the health risks of HTPs does not support the much lower levels of perceived harm that PMI’s consumer studies found.…”

“…PMI’s MRTP application for IQOS makes reduced risk claims about IQOS that, like its earlier ‘light’ and ‘mild’ claims that were deemed fraudulent in the RICO case, are not substantiated by PMI’s own internal research reported in its application 2 – 4 . Several of the other papers in this supplement indicate that IQOS is not significantly less harmful than combusted cigarettes 2 – 4 46 47 and that while IQOS had lower levels of pulmonary cytotoxicity 48 and carcinogens 49 than combusted cigarettes, they were higher than those of e-cigarettes.…”

“…Because of the growing evidence of severe negative health effects of smoking and smokers’ concerns about their health, tobacco companies have been motivated to create ‘safer cigarettes’ since the 1960s, and in 1988 they first introduced HTPs, marketing them as less harmful than combusted cigarettes. While HTPs produce different toxic chemicals than combusted cigarettes, 2 the human health effects of HTPs are not completely understood and the evidence that PMI submitted to the US Food and Drug Administration (FDA) revealed that, in terms of the clinical biomarkers of disease 3 or pulmonary and immune toxicity, 4 IQOS was not significantly different from cigarettes.…”

Heated tobacco products: another tobacco industry global strategy to slow progress in tobacco control

“…However, emerging science indicated that HTP are unlikely to be any ‘healthier’ than conventional cigarettes, including scientific data submitted by PMI as part of its MRTP application to the FDA 8 , 10 , 74 – 77 . The industry’s claims are often speculative, emphasising the ‘potential’ for these new products to either reduce harm or reduce risk of tobacco use 78 , 79 .…”

“…The application to sell in the USA without these claims falls under a different process 7 . In particular, despite evidence to the contrary in their MRTP application, 8 – 10 PMI claimed that smokers who switch completely to IQOS would experience a reduction in the health-related risks associated with smoking 11 , 12 . In January 2018, the FDA Tobacco Product Scientific Advisory Committee recommended against FDA approval of reduced risk claims for IQOS 13 .…”