Компенсация расходов на питание и проживание сотрудников облагается страховыми взносами

PMI’s US 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

(Updates headline)

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 initially address each example but said some of the language flagged by campaigners was,
in the company’s view, compatible with the FDA’s orders.

On Tuesday, the spokesperson added that this was
true all of the language cited in the campaigners’ letter.

«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.

PMI is preparing to sell an older IQOS device in four U.S.
cities. However, it has said it will not pursue a full U.S.

launch until the newer version of its device gets FDA authorisation.

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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A billionaire couple have won the right to remove a single tree
from the driveway of their lavish $20million mansion after being blocked by their local council. 

Paul Holmes a Court, the son of Australia’s first billionaire Robert Holmes a Court,
and his wife Zara had been at loggerheads with their local council
over a request to remove a single peppermint tree growing in the middle
of their driveway.

The couple bought the four-bedroom mansion in the affluent, tree-lined suburb overlooking Perth’s Freshwater Bay for $20.1million in August.

They wanted to remove the tree but the Shire of Peppermint Grove refused the request on the grounds the tree was not dead or deceased. 

‘We are very lucky to live here, but I have to say that
the tree placement is unusual,’ Ms Holmes a Court previously told a council meeting. 

‘I’m quite a reasonable and rational person, but a
tree in the middle of the driveway makes it quite tricky to reverse out.’

The couple enjoyed a breakthrough at a council meeting last week after an alternative motion was unanimously passed that allowed
the tree to be removed on the condition they paid a $2,500 bond before any work was
done on the driveway.

They will also need to plant two replacement trees on their property.

Paul Holmes a Court (pictured) is the son of Australia’s first billionaire, famed tycoon Robert
Holmes a Court, who died suddenly of heart failure at the age of 53

Paul Holmes à Court and his wife Zara won a council battle to
remove a peppermint tree (pictured) from the driveway of their $20million mansion

Ms Holmes a Court previously claimed the tree’s odd placement also made it difficult
to spot cars turning the corner at a nearby intersection with
Bay View Terrace.

After the motion to remove the tree was passed
at the meeting, councillor Douglas Jackson said it
was a ‘good outcome’.

‘I think it meets both the owners’ wants, or expectation, but also
matches the council’s needs at the same time by ensuring that there is tree cover on the verge
of that property,’ he said.

Peppermint Grove is hoping to implement a policy that would
even make it an offence to damage or remove any mature trees on private
property without council approval.

Last month, WA Planning Minister John Carey said
he hoped the Shire of Peppermint Grove would ‘take a common sense approach’ to
the issue.

‘This is part of the challenge that we do have with local government.

I’ve always been on the record that we need local governments to
take a common sense approach to issues,’ Mr Carey told the West Australian. 

‘And I understand people are passionate about trees.
But ultimately, we do need local governments to assess the situation and find pragmatic outcomes.’

According to the online listing for the four-bedroom, four-bathroom mansion — which is built on a corner block along the banks
of the Swan River — the sprawling Federation-style property
was built in around 1904. 

The Holmes à Court property was built in around 1904 in Federation ‘Arts and Crafts’ style

The home boast an unparalleled view of the Swan River overlooking Fresh
Water Bay

‘Designed in the rare Federation ‘Arts and Crafts’ style,
the home has retained all its elegance and splendour
via lofty ceilings, sweeping verandas, charming decorative
arches, casement-style sash windows, and walls of French doors that bathe the home in light, reflecting river views beyond,’
the listing said.

The property also features ‘Plush Champagne-hued carpets’ and
‘cobble-stoned remote garage to accommodate six cars,
abundant storage, gym area, double vanity rain-shower bathroom and climate-controlled wine cellar.’

Mr Holmes a Court is the chief executive of prize-winning wine label Vasse Felix and the brother of Peter Holmes à Court, who once jointly owned of the South Sydney Rabbitohs
with Russell Crowe, and climate philanthropist
Simon Holmes à Court.

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