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    PMI's U.S. launch of flagship IQOS device needs FDA green light

    *

    Six health campaign groups wrote letter to FDA criticising PMI Say PMI
    misrepresented past FDA decisions on IQOS

    *

    PMI says it discusses its products in accordance with law

    *

    FDA acknowledges receiving campaigners' letter

    By Emma Rumney

    LONDON, July 16 (Reuters) - Health campaigners have written to U.S.
    regulators accusing Philip Morris International of misrepresenting past regulatory decisions, seeking to disrupt
    the launch of its flagship heated tobacco device IQOS in the
    United States.

    The world's biggest tobacco company by market value has spent billions
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    But it needs permission from the U.S. Food and Drug
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    These factors "directly bear on whether PMI should be permitted to market IQOS" in the United States, the campaigners' letter
    said.

    The contents of the letter have not been previously reported.


    Asked by Reuters to respond to the letter, a PMI spokesperson said the company was proud to discuss the FDA's
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    The spokesperson did not address each example but said some of
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    Reuters could not determine whether the campaigners' letter would change the FDA's approach to
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    Devices like IQOS heat up sticks of ground tobacco
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    The FDA first authorised PMI to sell an older version of IQOS in 2019.
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    The FDA can also issue a "risk modification order", authorising a company to claim its product reduces
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    The FDA rejected PMI's previous application to say its older IQOS device
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    PMI applied in 2023 to renew its existing exposure modification orders.
    Later that year, it also applied to sell and market a newer version of the
    IQOS device in the same way. The FDA has yet to decide on these applications.


    Marketing the product as having health benefits compared to traditional cigarettes
    could help PMI persuade consumers to switch as well as afford it
    tax benefits versus cigarettes in some U.S. states.



    SWITCH RATES

    The campaign groups also cited preliminary data from ITC studies in Japan and Korea,
    saying it contradicted PMI's findings about how many IQOS users completely switch from cigarettes.


    The studies have been presented at academic conferences but have not yet been submitted for publication in a journal, ITC researchers told Reuters.
    As a result, study abstracts have been peer reviewed but
    the full findings have yet to go through that
    process.

    Japan is IQOS' largest market and the introduction of heated tobacco there coincided with an accelerated decline in cigarette
    sales.

    PMI estimates more than seven out of 10 of its registered IQOS customers globally have quit cigarettes.

    A 2023 PMI application to the FDA emphasised that the majority
    of IQOS users were using IQOS exclusively.

    However, the ITC's researchers put the percentage of
    all IQOS users that had quit smoking at just 15% in Japan and 30% in Korea
    in 2021.

    Users most commonly used IQOS and cigarettes simultaneously, known as "dual use", often leading to an overall
    increase in tobacco consumption, the ITC researchers found.


    PMI pointed to a 2019 Japanese government health survey,
    where 75% of respondents who reported using heated tobacco said they did not smoke.


    However, a paper published this year, led by researchers from Georgetown University, highlighted flaws
    in the government's survey, including changes to the question format that can lead to under-reporting of smoking.


    Other surveys have also found higher rates of dual
    use than the government, it said.

    (Reporting by Emma Rumney; Editing by Matt Scuffham and
    Emelia Sithole-Matarise)

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