IQOS 3 Approved By The FDA

The Food and Drug Administration (FDA) announced that they have approved the IQOS 3 system for sale in the United States by Altria Group and Philip Morris International (PMI).

According to the scientific findings handed down by the FDA’s Center for Tobacco Products, the applicants — Altria Group and PMI — adequately demonstrated that the scientific grounds for approving the updated variation of the IQOS product meets the legal criteria for the appropriate “protection of the public health” within the United States.

Upon review of findings documentation, the majority of the changes that were approved for the new IQOS device were aesthetic. Given that a prior version of the IQOS system was already approved by the FDA as an approved PMTA product and a modified risk tobacco product, this marketing authorization is a step forward for tobacco harm reduction products that don’t emit smoke and are virtually risk-reduced through every characteristic of the product’s design.

“Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch,” said Mitch Zeller, an American attorney and the director of the FDA’s Center for Tobacco Products, on July 7, 2020. “The FDA will closely monitor how IQOS is used by consumers to determine if these products meet this potential and do not cause increased use among youth. It is important to note that these products are not safe, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product.”

For the latest authorization of the IQOS 3 system, corporate heads at Altria, PMI, and Philip Morris Products S.A. (one of PMI’s U.S. subsidiaries) have applauded the FDA approval.

“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,” said  André Calantzopoulos, PMI’s chief executive. in a press release. “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.”

Chief executive Jon Moore, the head of Philip Morris USA (an Altria subsidiary), also reacted positively to the approval of IQOS 3.

“Altria’s 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we’re excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets,” said Moore.