Philip Morris International Announces U.S. Food and Drug Administration Authorization of IQOS 3 for Sale in the United States
New York, United States:
The U.S. Food and Drug Administration (FDA) today confirmed that IQOS 3, Philip Morris International’s electrically heated tobacco system, is appropriate for the protection of public health and has authorized it for sale in the United States. FDA’s decision follows an assessment of a premarket tobacco product application (PMTA) filed with the agency in March 2020.
The IQOS 3 device contains a number of technological advancements, compared to a previously authorized IQOS device, including longer battery life and quicker recharge between uses.
In its decision the FDA noted that:
- International survey data reviewed by the agency found no evidence of increased uptake of IQOS by youth or young adults, while use patterns available for a previously authorized version of IQOS within the U.S. have not raised new concerns regarding product use in youth and young adults.
Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, 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.”
He added, “The order is subject to the same comprehensive commercialization requirements set in the April 2019 PMTA marketing orders for IQOS 2.4, which aim to maximize the opportunity for adults to switch from cigarettes, while minimizing unintended use. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.”
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