The role of postmarket safety surveillance in supporting PMI’s MRTP application
PMI established a safety surveillance system in concomitance with the initial launch of our Tobacco Heating System (THS), commercialized as IQOS. In addition to the collection and reporting of adverse incidents, aggregate data analyses, including signal detection activities, are performed to ensure prompt identification of risks and communication with relevant parties.
On 7 July 2020, the FDA authorized the marketing of IQOS as an MRTP with reduced exposure claims. To reach a decision to authorize marketing of a proposed MRTP under section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA must consider:
- The relative health risks to individuals of the tobacco product
- The increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product
- The increased or decreased likelihood that people who do not use tobacco products will start using the tobacco product
- The risks and benefits to people from the use of the tobacco product as compared with the use of products for smoking cessation approved as medical products to treat nicotine dependence
- Comments, data, and information submitted by interested persons
Postmarket safety surveillance plays an important role in this process, contributing data on points 1, 4, and 5 above.
Safety surveillance of THS
Between the commercial launch of THS in November 2014 and December 31, 2023, postmarket data have shown a steady safety profile for THS products. At the same time, the number of users has increased from fewer than 5,000 to more than 30 million. Over this period, most of the AEs assessed were nonserious, with only 2.29% of cases meeting the seriousness criteria. The most frequently reported AEs are shown in the graph below.