23 January 2020
The U.S. Food and Drug Administration (FDA) announced that as part of its ongoing review process, it has re-opened the public comment period for Philip Morris International Inc.’s (PMI) Modified Risk Tobacco Product applications (MRTP) for IQOS, the company’s electrically heated tobacco system.
The agency’s action follows a summary report submitted by PMI made in response to a request for clarification from the Agency regarding PMI’s 18-month A/J mouse lung cancer and chronic toxicity study. PMI submitted the study in August 2018 in support of the IQOS MRTP applications.
The comment period will remain open until February 24, 2020.
The summary report does not include any new data, but provides context for the data that was previously submitted.
Our conclusions from the study results remain unchanged: Exposure to IQOS aerosol did not cause an increase in incidence or multiplicity of lung tumors in neither female nor male A/J mice compared to air. In contrast, cigarette smoke exposure led to a significant increase in lung tumors.
- · The results of the A/J mouse study are in-line with the totality of evidence PMI has generated across a range of scientific disciplines, and smoking-related disease, showing that IQOS is a much better choice than continuing to smoke.
- · However, the FDA continues to review our MRTP applications.
- · PMI fully supports the transparency, thoroughness and the rigor of the agency’s MRTP review process.
PMI’s summary report, along with the complete Platform 1 IQOS MRTP evidence package, are available here.
In their request, the FDA sought to learn why IQOS Platform 1 aerosol-exposed male A/J mice had a lower survival rate than air-exposed mice in this particular study. Based on all available data, this reduced survival rate cannot be linked to IQOS Platform 1 aerosol composition. In this case, the limitation was related to a congenital abnormality that is a result of deliberate inbreeding for these mice and does not affect the respiratory tract. In fact, similar outcomes have been seen in other studies using this and other mouse strains. Mortality rates due to genetic defects in mice are not relevant to humans.
Learn more about the meaning and conclusions of this 18-month A/J mouse study.
About our Applications
- · In December 2016, PMI submitted MRTP applications for the IQOS device and three HeatStick variants: Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks; and Marlboro Fresh Menthol HeatSticks.
- · The initial public comment period for PMI’s MRTP applications was closed on February 11, 2019.
- · On April 30, 2019, the FDA authorized a version of PMI’s IQOS and its consumables for sale in the U.S. through issuance of premarket tobacco marketing orders, which is available in the U.S. market through an exclusive license with Altria Group, Inc.