Good news for US iQOS users! The US Food and Drug Administration (FDA) announced on Monday, December 7,2020 that it has authorized the sale of iQOS 3.0 in the United States. In 2019, the FDA approved the sale of several iQOS products, but only one device was included; iQOS 2.4, older The iQOS model. Nearly a year later, in March 2020, Philip Morris International (PMI) submitted a pre-sale tobacco product application (PMTA) for iQOS 3.0.
(Picture: UWOO YM – a better alternative for iQOS 3.0)
The FDA’s statement on iQOS 3.0 PMTA reads: “Our review of the supplementary PMTA found that minor design changes [between iQOS 2.4 and iQOS 3.0] did not raise new concerns about health effects or changes in user behavior.” This means that compared with iQOS 2.4, they found that iQOS 3.0 no longer poses a threat to public health. It is important to note that although iQOS 2.4 and iQOS 3.0 have been authorized by the FDA, they have not yet been approved. This means that the FDA has not approved any product.
The FDA’s statement on approval reads: “The authorization of new tobacco products does not mean that they are safe.” We must also note that the classification of iQOS 2.4 as a high-risk tobacco product (MRTP) has nothing to do with iQOS 3.0.
This means that iQOS 3.0 cannot be sold as a risk-reducing product until the MRTP application is evaluated by the FDA. Nevertheless, PMI CEO André Calantzopoulos is very satisfied with the authorization announcement.
He said, “The agency’s decision to authorize iQOS 3 to be sold in the United States is an important step forward for the thousands of American men and women who currently smoke.
In just five years, approximately 11.7 million people in the world stopped smoking and switched to iQOS. We believe that bringing more modern iQOS to the United States will only accelerate the conversion of smoking adults. “PMI said that they will also seek MRTP classification for iQOS 3.0. In the meantime, let us enjoy the newly launched iQOS 3.0, which has longer battery life and faster charging time than iQOS 2.4.
