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utorok, 10 december 2024 23:16
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The Food and Drug Administration's top tobacco
scientist has accepted a job at tobacco giant Philip Morris International,
just weeks after he signed off on the company's latest vape product.
Matt Holman, chief of the office of science in the agency's Center for Tobacco
Products (CTP), announced his departure from the FDA
on Tuesday, effective immediately, after having served at
the agency for more than 20 years.
His departure adds to ongoing trouble within the FDA's tobacco control division, which
is currently under review by agency commissioner Robert Califf.
It also follows the division's loss of Mitch Zeller, who retired in April after serving as CTP director for nearly a decade. Brian King, who announced Holman's resignation in an internal memo, was appointed director earlier this month.
Matt Holman (left), the FDA's top tobacco scientist, has left the agency to work for Philip Morris International, the maker of Marlboro
cigarettes. His departure follows the division's loss
of Mitch Zeller (right), who retired in April after serving as CTP director for nearly a
decade
Changes to CTP's organizational structure come amid FDA efforts to regulate the vaping market and just weeks after the agency temporarily reversed its June
decision to ban Juul e-cigarettes from being sold in stores.
Philip Morris, although most known for its production of Marlboro cigarettes, is
also a producer of e-cigarettes, heated tobacco and oral nicotine products.
At CTP, Holman played a key role in e-cigarette approvals, including IQOS, a 'heat-not-burn' tobacco device produced by Philip
Morris International (PMI).
Although IQOS isn't currently sold in the US due to patent issues, it could possibly face new FDA reviews if those issues were
to be resolved.
The product is currently sold in Korea, Japan and other countries, but the firm hopes to resume sales in the US next year.
Holman told The New York Times on Wednesday that his role at PMI was 'broadly defined' but
involved working on tobacco harm-reduction efforts, noting he was drawn to the agency
because of its goal to push smokers from using cigarettes to noncombustible and less harmful products.
'They are taking the actions that I think would align with such a goal,' Holman said.
'And that's what really drew my attention to PMI. I'm going there not to
help them sell more cigarettes, but the opposite.'
The biochemist said he would also provide input on regulatory submissions.
A PMI spokesperson, in a statement to DailyMail.com on Thursday,
declined to give specifics about Holman's role at the firm but
said 'he will abide by all applicable post-government employment restrictions.'
'These restrictions prohibit Dr. Holman from appearing before or communicating with the
FDA on behalf of PMI regarding any matter for a period of one year.
'In addition, Dr. Holman is prohibited for a period of two years from
appearing before or communicating with the FDA on behalf of PMI regarding any matter that was pending under his official responsibility during his last
year of government service.
'Finally, Dr. Holman is permanently prohibited from appearing before or communicating with the FDA on behalf of PMI regarding any particular
matter in which he was personally and substantially involved during the entirety of his government service.'
Holman's departure comes just weeks after the federal regulator temporarily reversed
its June decision to ban Juul e-cigarettes from being
sold in stores. Philip Morris (NYC headquarters pictured) is also a producer of e-cigarettes and
e-vapor devices
Further details about his appointment will be disclosed at
a later date, but the spokesperson reiterated the company is 'looking forward' to Holman joining their team 'as
we continue to pursue a smoke-free future.'
Holman was earning more than $230,000 annually while working at CTP, according to 2020 income reports reviewed by FederalPay.org.
CTP director King's Tuesday memo - which was made public by Stat News Correspondent
Nicholas Florko - revealed Holman had been on leave prior
to his resignation.
King said the former chief 'recused himself, consistent with agency
ethics policies, from all CTP/FDA work while exploring career
opportunities outside of government.'
He also applauded Holman for helping CTP through a 'critical time,' which included 'including preparing for and overseeing review for the
bolus of premarket tobacco product applications.'
He said that although he and Holman 'didn't have an opportunity to work together,' he was 'grateful' for his contributions to the agency and 'wishes him well
in his next chapter.'
It is unclear what Zeller made as CTP director, as his income documents have been redacted.
However, Glassdoor reports the average FDA division direct salary is $200,891. Based on Holman's
salary, DailyMail.com analysts speculate Zeller was earning over $230,000 annually.
His departure was announced by CTP Director Brian King in a memo
on Tuesday, which has since been made public by Stat News Correspondent Nicholas Florko
Critics argue Holman's recent career change is concerning due to the 'revolving
door' between federal officials and corporations they regulate.
However, federal rules governing career changes do not prohibit an official who oversees regulatory matters from leaving the agency and then joining corporations with products under review.
Rules do restrict Holman - or any other former FDA employee - from appearing before the agency about issues
he 'participated personally and substantially during
government service.'
'This is legal. That's the bottom line,' Dr. Michael Carome, director of the Public Citizen health research group, told the Times. 'It's
this type of revolving door move that really undermines public
confidence in the agency.'
Critics argue Holman's career change is concerning due
to the 'revolving door' between federal officials
and corporations they regulate. PICTURED: Cigarettes moves along a machine during the assembly process at the Philip Morris International production facility in Medellin, Colombia in June 2017
Those skeptical of the move are also questioning the recent approval of the Philip Morris smokeless tobacco product which is an electronic device that, unlike e-cigarettes, contains tobacco.
Dr. Stanton Glantz, a retired professor of medicine, argued the agency's approval of IQOS 'disregarded valid scientific evidence and misapplied the public health standard mandated by
law.'
He claims Holman ignored a major study showing that e-cigarette use was not associated with
reduced smoking rates and that approving vapes is not combating the problem of dual-use
of cigarettes and e-cigarettes.
'He's the one who signed off on these approvals,' he
said. 'They deal with all of these issues by ignoring it, by relying on out-of-date studies.'
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Earlier this month, the FDA temporarily restored the sale of
Juul e-cigarettes after reviewing the company's appeal of a decision to pull the products from the market.
The FDA chose to reject the company's application to remain on store shelves in late June as part of a larger crackdown on teen smoking
and the tobacco industry overall.
While many other major e-cigarette manufacturers were allowed to remain on shelves, Juul was instead rejected.
The San Francisco, California, company appealed the decision.
Earlier this month, the FDA temporarily restored the sale of Juul e-cigarettes after reviewing the company's appeal
of a decision to pull the products from the market (file photo)
On July 5, America's top regulator agency cited 'scientific issues' as a
reason to stay the ban and allow the products to temporarily return.
'This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it,' the agency wrote in a tweet.
'All electronic nicotine delivery systems, or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed.
The stay and the agency's review does not constitute authorization to market,
sell, or ship JUUL products.'
Juul rocketed to popularity in the U.S. in the 2010s, as its fruit flavored nicotine products became trendy among younger smokers - leading to the company also shouldering blame for increases in teen smoking.
To limit rises in teen smoking, the FDA banned fruit flavored e-cigarette devices,
and forced each company to apply individually to allow their products to remain on shelves.
Juul was expected to have its application approved.
Juul has branded its products as devices that can help those addicted
to nicotine slowly ween themselves off safely - as vape devices
do not have many of the same downsides as smoking tobacco cigarettes do.
Instead, though, the fruity and mint flavors in many of its devices have led to many children and teens picking up smoking - when they
likely would not have otherwise.
This has placed Juul, and the e-cigarette market in general, in the FDA's crosshairs in recent years.
FDA -
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utorok, 10 december 2024 23:02
posted by iqos lumina one
A paradise for shoppers and a perfect destination for a real holiday, Singapore is worth visiting for a best shopping experience ever.
Singapore is amongst the only three existing self-governing city-states in the world at present
but there is something else that makes this island city stand apart others i.e.
Shopping at Singapore. This city has acquired the title of
" shopping Center" and is considered to have the most business
pally economy.
If you are a shopaholic, Singapore has all what you need.
There are numerous places to shop here, from the
most expensive branded malls like the Iluma and OG to the budgetary
streets like Bugis. The Centerpoint shopping center located at the Orchard road is amongst
the most touristy shopping hubs in the city. The location of this shopping mall makes it even more lively as it
is situated in the heart of the shopping district of Singapore.
On the other hand, a must visit entertainment and shopping center is the VivoCity mall that is beautifully architectured and renders multiple facilities
with the mesmerizing water front. This super shopping mall features huge play ground and
a wadding pool for kids that alleviates shoppers
to leave kids there to have a great shopping experience.
Singapore has a lot more for shoppers, check out the
most unique shopping destinations in the island city:
Books Actually
For those who love reading and relish time exploring books,
Books Actually is a perfect place. This unique bookshop located at Ann Siang Road
have a tremendous collection of even the
rarest of books specifically fictional literature.
Little India
Overcrowded and messy but highly tempting and colorful, Little India in Singapore is famous among all desirous locals and tourists for the last minute
shopping sprint. With the help of a walking guide,
one can enjoy the true shopping fun at Little India that is stuffed
into 700 by 500 meters area and includes various restaurants, art galleries and small stalls.
Sungei Road Thieves' Market
For the ones who see the world with a antithetic fashion, Sungei Road Thieves' Market located on Kelantan Road and
Weld Road, is the spot for you. The look-up for all retro and creaky stuff
ends in this oldest flea market of Singapore that offers a hot yet stupefying shopping experience.
There is a galore of shopping hotspots in Singapore and other most famed are Haji Lane, Parco Marina Bay, Mustafa
Centre, ION Orchard and Chinatown.
Foxysales, a Singapore based online shopping store, allows Singapore Sales, less expensive,
Shopping Singapore with great choice, better discounts explaining that Singapore online
shoppers prefer to shop at a local online store. -
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utorok, 10 december 2024 22:26
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