May 24, 2019
PMI Presents to US FDA Advisory Committee; Important Milestone in the Scientific Review of IQOS
First-ever consideration of a heated tobacco product, IQOS, by
FDA Advisory Committee
FDA, and PMI experts discuss comprehensive scientific approach and data set
- FDA’s careful review of PMI’s Modified Risk Tobacco Product applications for IQOS continues
The meeting was part of the FDA’s review of PMI’s request to commercialize IQOS in the US as a “Modified Risk Tobacco Product”. U.S. law and policy recognize product innovation as important to the 40 million American men and women who smoke.
To advise the Agency on PMI’s applications, the Committee covered a wide range of scientific, technical, and consumer-communications topics. It raised questions and probed the likelihood and magnitude of potential benefits as well as how best to address possible unintended use.
Although the Committee did not agree with some of the specific language of proposed risk and harm consumer communications, it confirmed that the evidence supported the statement that switching completely to IQOS significantly reduces exposure to harmful chemicals.
“The Committee’s two-day discussion was a milestone event. We thank
the Agency and the Committee for their interest in our scientific
dossier and our determination to enable adults who smoke to have access
to and information about better alternatives,” said André
Calantzopoulos, PMI’s Chief Executive Officer, who added: “I am
deeply grateful to my colleagues for their exceptional work on our
application to the
We believe the Committee’s interactions with presenters and its
discussion reflected respect for our scientific data and commitment to
bring IQOS to the U.S. The Committee delved into such areas as
inferences about long-term health outcomes, quantification and
comparison of risk, the best way to formulate consumer information, and
areas for post-market surveillance. At the end of the meeting, the
Members of the Committee discussed and voted on particular questions on
which the Agency requested the Committee’s views. TPSAC recommendations
and votes are not binding on the
“As a next step, we look forward to working with the Agency to
clarify outstanding points so as to best assist in their ongoing
decision-making process, which inherently entails a certain degree of
scientific uncertainty pre-market,” said Mr. Calantzopoulos, who
concluded: “As the
Since 2008, PMI has invested more than
Nearly 4 million adult smokers have already switched to IQOS. Our ambition is that all those who would otherwise continue smoking abandon cigarettes and switch completely to scientifically substantiated smoke-free products as soon as possible. Regulatory policies and decisions can substantially accelerate the speed and magnitude of this historic change.
Note to the editor
As previously announced, in 2018 PMI will complete a 12-month exposure response study designed to measure clinical risk markers in adult smokers who switch to IQOS.
PMI has also submitted a Pre-Market Tobacco Application (PMTA) to the
Under agreements with PMI,
We are a leading international tobacco company engaged in the
manufacture and sale of cigarettes and other nicotine-containing
products in markets outside
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