March 11, 2022
On March 11, FDA issued a modified risk granted order authorizing Philip Morris Products S.A. (PMPSA) to market the IQOS 3 System Holder and Charger with the following reduced exposure information:
“AVAILABLE EVIDENCE TO DATE:
- The IQOS system heats tobacco but does not burn it.
- This significantly reduces the production of harmful and potentially harmful chemicals.
- Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
This reduced exposure information is the same as the information previously authorized by FDA in July 2020 for an earlier version of the device.
Today’s action follows FDA’s review of a new modified risk tobacco product (MRTP) application submitted by the company for the IQOS 3 System Holder and Charger. This MRTP application primarily cross-referenced the supplemental premarket tobacco product application (PMTA) for this device, which was authorized for legal sale and distribution in the United States in December 2020, as well as the MRTP application for the previous version of the device. The IQOS 3 device is similar in design to the previous version (with mainly aesthetic changes), uses the same tobacco source, and the company requested to use the same exposure reduction claim as authorized for the previous version of the device. Given these similarities, FDA largely relied on its past evaluations of the IQOS 3 device and previous version of the device in determining that the IQOS 3 device meets the authorization criteria to be marketed as an MRTP.
Importantly, this action does not mean this product is safe or “FDA-approved.” There are no safe tobacco products, and those who do not use tobacco products should not start.
FDA is aware that IQOS and Heatsticks are currently banned for sale and import in the United States by the U.S. International Trade Commission. Today’s action does not override that ruling; rather it allows PMPSA to consider the authorized reduced exposure claim in the potential future marketing of IQOS 3. The modified risk granted order issued for the IQOS 3 System Holder & Charger is effective through July 7, 2024, barring, among other things, any finding that the order is no longer expected to benefit the health of the population as a whole.