Philip Morris International’s (PMI) prominent Heat-Not-Burn device, the IQOS, may not reduce harm enough to be considered for MRTP status by the FDA, Reuters reports.
PMI submitted their own research data to the FDA for review earlier this year.
The FDA has not yet made a decision. The agency requested review of IQOS data by a panel of scientists earlier this year. The expert panel did not recommend FDA approval of modified-risk status for the HNB product. PMI’s recently submitted data backs the panel’s original advice.
Smokers who switched from combustible cigarettes to the HNB devices did not show any marked improvement in lung function or reduced inflammation. “Philip Morris International’s own data shows that there will continue to be significant health risks associated with these products,” Dr. Farzad Moazed, lead author on a recently published IQOS study, told Reuters.
“While this reduces the amount of some of the harmful chemicals associated with smoking, it increases the levels of other chemicals, and the evidence to date shows that these products continue to result in harm,” Moazed said.
Philip Morris Fires Back
PMI responded in exactly the way a spoiled, petulant child would. Their official statement, comprised of a bullet point list, criticized the conditions and results of the study.
“The inflammatory responses observed in PMI non-clinical studies are small compared with the effects of cigarette smoke, and mostly occur at the highest IQOS exposure (>100 sticks/day),
which is not representative of human exposure,” PMI representatives wrote. The company argues that their own ‘Exposure Response clinical study,’ submitted with their MRTP application materials, include typical use endpoints for the inflammation and lung damage considerations.
What ‘Other Chemicals’ Means in HNB
It is difficult to determine the full effects of HNB products, as currently no longitudinal research exists to support or refute claims for either side. No research data exists to support whether IQOS actively helps smokers quit cigarettes, either. Researchers note without that data, dual-users (people who smoke cigarettes and use HNB products) risk increased exposure to dangerous carcinogens. PMI’s research data excluded dual-users from methods and results.
A research letter published in the peer-reviewed journal, Tobacco Control, determined recently that HTP (heated tobacco products) are about where one might expect them to fall with regard to certain carcinogens. HTP is another name for Heat-Not-Burn products.
In the Tobacco Control study, the research team found levels of TSNA (tobacco-specific nitrosamines) – a serious carcinogen in tobacco products – were only slightly lower than levels from combustible cigarettes. Conversely, e-cigarettes (specifically the MarkTen) contained significantly lower TSNA levels than both the IQOS and the cigarettes used in study (Marlboro Reds).
Read the initial Reuters report here.
Leigh NJ, Palumbo MN, Marino AM, et al Tobacco-specific nitrosamines (TSNA) in heated tobacco product IQOS Tobacco Control Published Online First: 21 September 2018. doi: 10.1136/tobaccocontrol-2018-054318
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