The landmark ruling follows a comprehensive and rigorous two-year assessment of the science in our Premarket Tobacco Product Application.
Unlike cigarettes, the IQOS system heats — but does not burn — tobacco. It is the first electrically heated tobacco product to qualify for sale in the US under the 2009 law that empowers the agency to regulate tobacco products. The US now joins 47 other countries where IQOS can be legally sold.*
“The FDA’s decision to authorize IQOS in the US is an important step forward for the approximately 40 million American men and women who smoke,” said André Calantzopoulos, PMI’s Chief Executive Officer. “Some will quit. Most won’t, and for them IQOS offers a smoke-free alternative to continued smoking.”**
In just two years, 7.3 million people around the world have abandoned cigarettes and switched completely to IQOS. Today’s decision by the FDA now makes this opportunity available to American adult smokers.
“All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation. FDA’s announcement is a historic milestone.”
He added: “The order sets out clear commercialization guidelines, including marketing requirements that maximize the opportunity for adults to switch from cigarettes, while minimizing unintended use. We fully support this objective. The FDA has set a high standard and we look forward to working with them to implement the order so that IQOS can reach the right audience – current adult smokers.”
PMI will bring IQOS to the US market through an exclusive license with Altria Group, Inc., whose subsidiary Philip Morris USA has the market expertise and infrastructure to ensure a successful launch.
PMI submitted a comprehensive body of scientific evidence in support of the application, which was submitted alongside an application in parallel for IQOS to be categorized as a “Modified Risk Tobacco Product.” This is still under review.
PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke.
*In April 2024, PMI ended its commercial relationship with Altria covering IQOS in the U.S. Read our press release for more details.
*André Calantzopouplos was speaking in his role as CEO at the time. On May 5, 2021, Jacek Olczak succeeded Mr. Calantzopoulos as CEO, and Mr. Calantzopoulos became Executive Chairman of the Board.
***The FDA authorization decision relates to IQOS 2.4.
