IQOS 3 DUO Receives FDA MRTP Authorization in the U.S.
The U.S. Food and Drug Administration has issued a modified risk granted order authorizing Philip Morris to market the IQOS 3 system holder and charger with reduced exposure information. The IQOS system heats tobacco but does not burn it, significantly re
The U.S. Food and Drug Administration has issued a modified risk granted order authorizing Philip Morris to market the IQOS 3 system holder and charger with the following reduced exposure information:
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 completely switching from conventional cigarettes to the IQOS system can significantly reduce your body’s exposure to harmful or potentially harmful chemicals.”
This reduced exposure information is the same as that previously authorized by the FDA in July 2020 for the earlier version of the device.
Today’s action follows the FDA’s review of a new Modified Risk Tobacco Product (MRTP) application submitted by the company for the IQOS 3 system holder and charger. That MRTP application primarily cross-referenced the supplemental premarket tobacco product application for the device, which was authorized in December 2020 for legal sale and distribution in the United States, 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 (mainly aesthetic changes), uses the same tobacco source, and the company requested the same reduced exposure claim that was authorized for the earlier version of the device. Given these similarities, the FDA relied heavily on its past evaluations of the IQOS 3 device and the previous version of the device in determining whether the IQOS 3 device met the authorization standards to be marketed as an MRTP.
Philip Morris, headquartered in Switzerland, is currently barred from importing the product into the United States following an unfavorable ruling in a patent dispute with a Reynolds American subsidiary of British American Tobacco.
PMI CEO Jack Olczak said in an interview with Bloomberg that the company plans to manufacture IQOS in the United States to work around the import ban.
