IQOS 3.0 Authorized for Sale in the United States
Good news for IQOS users in the US. On Monday, December 7, the US Food and Drug Administration (FDA) announced that it has authorized IQOS 3.0 for sale in the United States. In 2019, the FDA approved the sale of several IQOS products, but only one device
Good news for IQOS users in the United States! On Monday, December 7, the U.S. Food and Drug Administration (FDA) announced the authorization for 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, the older model of IQOS. Nearly a year later, in March 2020, Philip Morris International (PMI) submitted a premarket tobacco product application (PMTA) for IQOS 3.0.
In the FDA's statement regarding the IQOS 3.0 PMTA, it was noted: “[Our review of the supplemental PMTA found that the minor design changes between IQOS 2.4 and IQOS 3.0 did not raise new concerns regarding health effects or changes in use behavior.” This means that compared to IQOS 2.4, they found that IQOS 3.0 no longer poses a threat to public health. It is important to note that although both IQOS 2.4 and IQOS 3.0 have been authorized by the FDA, they have not been approved. This means the FDA has not recognized either product.
The FDA's statement regarding approval stated: “The authorization of new tobacco products does not mean they are safe.” We must also note that the classification of IQOS 2.4 as a modified risk tobacco product (MRTP) is unrelated to IQOS 3.0.
This means that IQOS 3.0 cannot be marketed as a reduced-risk product until the MRTP application is evaluated by the FDA. Nevertheless, PMI's CEO André Calantzopoulos expressed satisfaction with the authorization announcement.
He stated, “The agency's decision to authorize the sale of IQOS 3 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 worldwide have quit smoking and switched to IQOS, and we believe that bringing the more modern IQOS to the United States will only accelerate the transition for adult smokers.” PMI also stated that they will seek MRTP classification for IQOS 3.0. In the meantime, let’s enjoy the newly launched IQOS 3.0, which has a longer battery life and faster charging time compared to IQOS 2.4.
In the FDA's statement regarding the IQOS 3.0 PMTA, it was noted: “[Our review of the supplemental PMTA found that the minor design changes between IQOS 2.4 and IQOS 3.0 did not raise new concerns regarding health effects or changes in use behavior.” This means that compared to IQOS 2.4, they found that IQOS 3.0 no longer poses a threat to public health. It is important to note that although both IQOS 2.4 and IQOS 3.0 have been authorized by the FDA, they have not been approved. This means the FDA has not recognized either product.
The FDA's statement regarding approval stated: “The authorization of new tobacco products does not mean they are safe.” We must also note that the classification of IQOS 2.4 as a modified risk tobacco product (MRTP) is unrelated to IQOS 3.0.
This means that IQOS 3.0 cannot be marketed as a reduced-risk product until the MRTP application is evaluated by the FDA. Nevertheless, PMI's CEO André Calantzopoulos expressed satisfaction with the authorization announcement.
He stated, “The agency's decision to authorize the sale of IQOS 3 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 worldwide have quit smoking and switched to IQOS, and we believe that bringing the more modern IQOS to the United States will only accelerate the transition for adult smokers.” PMI also stated that they will seek MRTP classification for IQOS 3.0. In the meantime, let’s enjoy the newly launched IQOS 3.0, which has a longer battery life and faster charging time compared to IQOS 2.4.
