IQOS 3.0 Authorized for Sale in the U.S.
Fantastic news for American IQOS users! The United States Food and Drug Administration (FDA) announced Monday that it has authorized the sale of IQOS 3.0 in the U.S.
In 2019, the FDA authorized several IQOS products for sale, however only one device was included in that; IQOS 2.4, an older IQOS model.
Nearly one year later, in March of 2020, Philip Morris International (PMI) filed a Premarket Tobacco Product Application (PMTA) for IQOS 3.0. An FDA statement regarding the IQOS 3.0 PMTA reads “[our] review of supplemental PMTA finds that the minor design changes [between IQOS 2.4 and IQOS 3.0] do not raise new concerns related to health effects or changes in use behavior.” This means that they do not find IQOS 3.0 to pose anymore a risk to public health than IQOS 2.4.
It is important to note that although IQOS 2.4 and IQOS 3.0 have been authorized by the FDA, they have not been approved. This means that the FDA has not endorsed either product. An FDA statement regarding approval reads “the authorization of new tobacco products doesn’t mean they are safe.”
We also must note that the classification of IQOS 2.4 as a Modified-Risk Tobacco Product (MRTP) has no bearing on IQOS 3.0. Meaning that until a MRTP application is and assessed by the FDA, IQOS 3.0 cannot be marketed as a reduced-risk product. Nevertheless, PMI’s Chief Executive Officer, André Calantzopoulos, appeared pleased with the authorization announcement. He said “The agency’s decision to authorize IQOS 3 for sale in the U.S. is another important step forward for the tens of millions of American men and women who currently smoke. In just five years, approximately 11.7 million people around the world have stopped smoking and switched to IQOS, and we believe bringing a more modern version of IQOS to the U.S. will only accelerate switching by adults who smoke.” PMI has indicated that they will seek MRTP classification for IQOS 3.0 also. In the meantime, let’s enjoy the newly available IQOS 3.0, which has a better battery life and quicker recharge time than IQOS 2.4.