PMI's U.S. launch of flagship IQOS device needs FDA green light
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Six health campaign groups wrote letter to FDA criticising PMI Say PMI misrepresented past FDA decisions on IQOS
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PMI says it discusses its products in accordance with law
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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 of dollars developing
the product, which investors see as key to driving future
growth. But it needs permission from the U.S.
Food and Drug Administration to sell it in the world's second largest
tobacco market by revenue.
Six anti-tobacco and health groups, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics and the American Lung Association, wrote to the FDA to
oppose IQOS-related applications PMI has submitted to
the agency.
"PMI has repeatedly made misleading and deceptive statements wrongly suggesting that the FDA has found that IQOS reduces the risk of disease," the
letter, dated June 27 and reviewed by Reuters, said.
The campaign groups allege that PMI violated the FDA's orders by suggesting IQOS offered lower risks than cigarettes.
Their letter cited four examples of such statements in the United States, the Philippines, Mexico and Kazakhstan.
They also said in the letter that upcoming independent studies contradict PMI's findings about how many IQOS
users completely switch to the device from cigarettes.
Presentations on the studies from the International Tobacco Control Project (ITC) at Canada's University of Waterloo are attached to the letter as
exhibits.
They show the ITC found a far lower rate of IQOS users had
quit smoking in Japan and Korea than estimates from PMI.
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 conclusions on IQOS.
The spokesperson did not address each example but said some of the
language flagged by campaigners was, in the company's view, compatible with the FDA's orders.
"Wherever we discuss our science and our products, we do so in accordance with all applicable laws," the spokesperson said.
Reuters could not determine whether the campaigners' letter would
change the FDA's approach to IQOS. The agency said it had received the letter and would respond directly
to the senders. It did not comment further.
Devices like IQOS heat up sticks of ground tobacco without burning them in an attempt to avoid the harmful chemicals released via
combustion.
The FDA first authorised PMI to sell an older version of IQOS in 2019.
It subsequently authorised the company to market it as offering reduced exposure to harmful chemicals versus cigarettes for smokers who completely switch - known as an "exposure modification order".
The FDA can also issue a "risk modification order",
authorising a company to claim its product reduces the risk of tobacco-related harm and disease.
But this is harder to prove, especially without long-term, epidemiological studies.
The FDA rejected PMI's previous application to say its older IQOS
device results in reduced health risks, saying there wasn't sufficient evidence to
support this.
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 review iqos iluma one
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)