News | Regulation | Dec 11, 2017

      PMI Presents to US FDA Advisory Committee

      Important Milestone in the Scientific Review of THS

      TIME TO READ: 3.5 MIN
      • First-ever consideration of a heated tobacco product, IQOS, by FDA Advisory
      • Committee 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 continue

      LAUSANNE, Switzerland--(BUSINESS WIRE)--On January 24 and 25, experts from Philip Morris International Inc. (PMI) and Philip Morris USA Inc. presented to the Tobacco Products Scientific Advisory Committee (TPSAC) before the US Food and Drug Administration (FDA).

      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 FDA and for the presentations last week. Our science and the commitment of our people give me confidence that we will realize our vision of a smoke-free future.”

      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 FDA.

      “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 FDA routinely does with regard to the many products it regulates, I believe the Agency will ultimately address that uncertainty in the best interest of people who smoke.”

      Since 2008, PMI has invested more than USD 3 billion in scientific research, product and commercial development, and production capacity related to IQOS and other smoke-free products. In 2017, over 70% of global R&D expenditure and over 30% of global commercial expenditure was allocated to smoke-free products, and we plan to invest more than USD 1.7 billion in facilities to manufacture them.

      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

      The FDA is reviewing PMI’s MRTP applications pursuant to the provisions of a 2009 Statute that granted the Agency authority with respect to tobacco products. Under the Statute, the FDA’s decision takes account of scientific evidence as well as comments, data, and information submitted by interested persons.

      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 FDA which, if granted, will permit the commercialization of IQOS in the US without modified risk messages. This application was not before the Committee as it follows a separate regulatory pathway.

      Under agreements with PMI, PM USA is licensed to sell IQOS in the U.S. should PMI receive a PMTA marketing order from the FDA.

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      PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
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      Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.