August 30, 2018

Stanton A. Glantz, PhD

Two more peer reviewed papers find that PMI’s own data shows IQOS is more dangerous than PMI claims, likely as bad as cigarettes

Tobacco Control just published “IQOS: examination of Philip Morris International’s claim of reduced exposure” and “Assessment of industry data on pulmonary and immunosuppressive effects of IQOS” that provide insights based on the information PMI provided to FDA as part of its Modified Risk Tobacco Product IQOS.

PMI is making a big deal about the fact that IQOS delivers lower levels of many toxins than conventional cigarettes.  They ignore the fact that their own data show higher levels – sometimes much higher levels – of others.

Other information shows that IQOS generates significant pulmonary harm, including adverse effects on the immune system in the lung that compromise lungs’ ability to resist infection.  These effects do not appear to significantly different from conventional cigarettes.

These results are consistent with the other papers that concluded that the adverse health effects of IQOS are not all that different from cigarettes.

Thus, a careful reading of the data that PMI submitted to FDA do not support either PMI’s reduced risk or reduced (overall) exposure claims.  For the same reasons, FDA should not approve PMI’s new product application to sell IQOS (a separate decision) because doing so would not be “appropriate for the protection of the public health,” the standard for decision making in the law.

This information is also important outside the USA where PMI is aggressively pressing its claims that IQOS is an effective harm reduction product.  Policymakers need not to be fooled by these claims and keep IQOS out of their countries.


Here are the abstracts for the two papers:

St.Helen G, Jacob III P, Nardone N, et al.   IQOS: examination of Philip Morris International’s claim of reduced exposure  Tobacco Control Published Online First: 29 August 2018. doi: 10.1136/tobaccocontrol-2018-054321.  It is available open access here.

Background New 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.

Methods We 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.

Findings PMI 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.

Conclusion PMI’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.


Moazed F, Chun L, Matthay MA, et al   Assessment of industry data on pulmonary and immunosuppressive effects of IQOS.  Tobacco Control Published Online First: 29 August 2018. doi: 10.1136/tobaccocontrol-2018-054296.  It is available open access here.

Introduction Heated 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.

Methods We reviewed Philip Morris International’s MRTP application to assess the pulmonary and immune toxicities associated with IQOS use in both animal and human studies.

Results Among 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.

Conclusion IQOS 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.

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